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This is a Phase II multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)-controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumab formulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in participants with subfoveal neovascular age-related macular degeneration (nAMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Port Delivery System with Ranibizumab 10mg/mL | Experimental | Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
|
| Port Delivery System with Ranibizumab 40mg/mL | Experimental | Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
|
| Port Delivery System with Ranibizumab 100mg/mL | Experimental | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
|
| Intravitreal Injection with Ranibizumab 0.5mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria | Protocol-Defined Refill Criteria At 1 month after initial fill:
For subsequent assessments:
| Baseline up to approximately 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10 | Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. | Baseline, Months 9, 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Mesa | Arizona | 85206 | United States | ||
| Retinal Research Institute, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39209113 | Derived | Campochiaro PA, Eichenbaum D, Chang MA, Clark WL, Graff JM, Le Pogam S, Cavichini Cordeiro M, Gune S, Rabena M, Singh N, Lin S, Callaway N. Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2025 Feb;9(2):144-155. doi: 10.1016/j.oret.2024.05.021. Epub 2024 Aug 30. | |
| 39154860 |
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Participants with subfoveal neovascularization secondary to AMD diagnosed within 9 months and treated with ITV anti-VEGF agents were enrolled in the study. Written informed consent was obtained before initiation of any study-related procedures. A participant's screening occurred no sooner than 7 days following administration of the last ITV ranibizumab treatment to the study eye. The screening visit was followed by the randomization visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Port Delivery System With Ranibizumab 10mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2018 | Feb 23, 2021 |
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Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| Change From Baseline in BCVA Over Time | Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. | Baseline up to Month 10 |
| Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis) | Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented). | Baseline up to Month 10 |
| Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) | Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea | Baseline up to Month 9 |
| Number of Implant Clogging at Month 9 | Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging. | Month 9 |
| Observed Maximum Serum Concentration (Cmax) of Ranibizumab | The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | Predose (0 hour) on Day 1 up to 38 months |
| Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab | AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field) |
| Time to Maximum Concentration (Tmax) of Ranibizumab | The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | Predose (0 hour) on Day 1 up to 38 months |
| Terminal Half-Life (t1/2) of Ranibizumab | The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | Predose (0 hour) on Day 1 up to 38 months |
| Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab | Predose (0 hour) on Day 1 up to 38 months |
| Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately Month 38 |
| Percentage of Participants With Positive Serum Antibodies to Ranibizumab | Baseline up to 38 months |
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States |
| The Retina Partners | Encino | California | 91436 | United States |
| Jacobs Retina center at the Shiley eye Institute UCSD | La Jolla | California | 92037 | United States |
| Jules Stein Eye Institute/ UCLA | Los Angeles | California | 90095-7000 | United States |
| N CA Retina Vitreous Assoc | Mountain View | California | 94040 | United States |
| Retinal Consultants Med Group | Sacramento | California | 95825 | United States |
| West Coast Retina Medical Group | San Francisco | California | 94109 | United States |
| UCSF; Ophthalmology | San Francisco | California | 94143 | United States |
| Orange County Retina Med Group | Santa Ana | California | 92705 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Retina Consultants of Southern | Colorado Springs | Colorado | 80909 | United States |
| Colorado Retina Associates, PC | Lakewood | Colorado | 80228 | United States |
| Florida Eye Microsurgical Inst | Boynton Beach | Florida | 33426 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Assoc of FL | St. Petersburg | Florida | 33711 | United States |
| Retina Associates of Florida, LLC | Tampa | Florida | 33609 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Illinois Retina Associates | Joliet | Illinois | 60435 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Johns Hopkins Med; Wilmer Eye Inst | Baltimore | Maryland | 21287 | United States |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| Retina Specialists | Towson | Maryland | 21204 | United States |
| Vitreo-Retinal Associates, PC | Worcester | Massachusetts | 01605 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49546 | United States |
| Vitreoretinal Surgery | Edina | Minnesota | 55435 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Retina Center of New Jersey | Bloomfield | New Jersey | 07003 | United States |
| Mid Atlantic Retina - Wills Eye Hospital | Cherry Hill | New Jersey | 08034 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico; School of Med | Albuquerque | New Mexico | 87131 | United States |
| Retina Assoc of Western NY | Rochester | New York | 14620 | United States |
| Char Eye Ear &Throat Assoc | Charlotte | North Carolina | 28210 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Retina Northwest | Portland | Oregon | 97221 | United States |
| Oregon HSU; Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Palmetto Retina Center | Florence | South Carolina | 29501 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Tennessee Retina PC. | Nashville | Tennessee | 37203 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Retina Research Center | Austin | Texas | 78750 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Med Center Ophthalmology Assoc | San Antonio | Texas | 78240 | United States |
| Retina Associates of Utah | Salt Lake City | Utah | 84107 | United States |
| Wagner Macula & Retina Center | Norfolk | Virginia | 23502 | United States |
| Derived |
| Eichenbaum DA, Freeman WR, Chang MA, Brooks L, Chaudhry N, Dadgostar H, McCannel CA, Michels M, Mittra RA, Wolfe JD, Beindl VC, Jaycock P, Bobbala A, Gune S, Spicer G, Callaway N. Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development. Ophthalmol Retina. 2025 Feb;9(2):127-143. doi: 10.1016/j.oret.2024.08.005. Epub 2024 Aug 16. |
| 35759124 | Derived | Wykoff CC, Campochiaro PA, Pieramici DJ, Khanani AM, Gune S, Maia M, Kagedal M, Ding HT, Maass KF. Pharmacokinetics of the Port Delivery System with Ranibizumab in the Ladder Phase 2 Trial for Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2022 Oct;11(5):1705-1717. doi: 10.1007/s40123-022-00532-9. Epub 2022 Jun 27. |
| 35589078 | Derived | Awh CC, Barteselli G, Makadia S, Chang RT, Stewart JM, Wieland MR, Brassard R, Callaway NF, Gune S, Heatherton P, Malhotra V, Willis JR, Pieramici DJ. Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab. Ophthalmol Retina. 2022 Nov;6(11):1028-1043. doi: 10.1016/j.oret.2022.05.011. Epub 2022 May 16. |
| 35248647 | Derived | Yohe S, Maass KF, Horvath J, Rea J, Barteselli G, Ranade SV. In-vitro characterization of ranibizumab release from the Port Delivery System. J Control Release. 2022 May;345:101-107. doi: 10.1016/j.jconrel.2022.03.005. Epub 2022 Mar 4. |
| FG001 | Port Delivery System With Ranibizumab 40mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| FG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| FG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Port Delivery System With Ranibizumab 10mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| BG001 | Port Delivery System With Ranibizumab 40mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| BG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| BG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria | Protocol-Defined Refill Criteria At 1 month after initial fill:
For subsequent assessments:
| Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment, excluding 5 participants who were given surgery. | Posted | Median | 80% Confidence Interval | Months | Baseline up to approximately 38 months |
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| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10 | Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. | Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations:
| Posted | Mean | 95% Confidence Interval | Units on scale | Baseline, Months 9, 10 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in BCVA Over Time | Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. | Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations:
| Posted | Mean | 95% Confidence Interval | Units on scale | Baseline up to Month 10 |
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| Secondary | Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis) | Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented). | Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations:
| Posted | Mean | Standard Deviation | Units on scale | Baseline up to Month 10 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) | Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea | Efficacy Population defined as all participants who received at least one study treatment. Here, "Number of Participants analyzed" indicates Number of Participants Included in MMRM Analysis. Assessments are censored for PDS participants meeting the following situations:
| Posted | Mean | 95% Confidence Interval | microns | Baseline up to Month 9 |
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| Secondary | Number of Implant Clogging at Month 9 | Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging. | Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. | Posted | Number | Participants | Month 9 |
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| Secondary | Observed Maximum Serum Concentration (Cmax) of Ranibizumab | The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab) | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Predose (0 hour) on Day 1 up to 38 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab | AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng∙day/mL | Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration (Tmax) of Ranibizumab | The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab) | Posted | Median | Full Range | days | Predose (0 hour) on Day 1 up to 38 months |
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| Secondary | Terminal Half-Life (t1/2) of Ranibizumab | The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics. | PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab) | Posted | Geometric Mean | Geometric Coefficient of Variation | days | Predose (0 hour) on Day 1 up to 38 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab | PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab) | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Predose (0 hour) on Day 1 up to 38 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs) | Safety analyses were based on the Safety Population which was composed of participants receiving at least one study treatment. | Posted | Count of Participants | Participants | Baseline up to approximately Month 38 |
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| Secondary | Percentage of Participants With Positive Serum Antibodies to Ranibizumab | Safety analyses were based on the Safety Population which was composed of participants receiving at least one study treatment. Here, number of analyzed participants represents number of participants from whom samples were collected and analyzed. Baseline evaluable participant is a participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant is a participant with an ADA assay result from at least one post-baseline sample. | Posted | Number | Percentage of Participants | Baseline up to 38 months |
|
Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Port Delivery System With Ranibizumab 10mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. | 1 | 58 | 14 | 58 | 57 | 58 |
| EG001 | Port Delivery System With Ranibizumab 40mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. | 2 | 62 | 19 | 62 | 59 | 62 |
| EG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. | 1 | 59 | 17 | 59 | 58 | 59 |
| EG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. | 1 | 41 | 4 | 41 | 35 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APLASTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ATRIAL FLUTTER | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL EROSION | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPOTONY OF EYE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| RETINAL HAEMORRHAGE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| RETINAL TEAR | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| RETINOPATHY PROLIFERATIVE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| RHEGMATOGENOUS RETINAL DETACHMENT | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| TRACTIONAL RETINAL DETACHMENT | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| ENDOPHTHALMITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| BRAIN CONTUSION | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| CERVICAL VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL FILTERING BLEB LEAK | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL RETRACTION | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| FRACTURE DISPLACEMENT | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPHAEMA | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| ILIOTIBIAL BAND SYNDROME | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| OCULAR PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| SKULL FRACTURED BASE | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| WOUND SECRETION | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA version 21.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA version 21.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DISORDER | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ADENOCARCINOMA GASTRIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
| |
| BREAST CANCER RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
| |
| LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
| |
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPERTENSIVE ENCEPHALOPATHY | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DEVICE DISLOCATION | Product Issues | MedDRA version 21.1 | Systematic Assessment |
| |
| DEVICE MALFUNCTION | Product Issues | MedDRA version 21.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| LUNG CONSOLIDATION | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| RESPIRATORY DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| AORTIC STENOSIS | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| FEMORAL ARTERY ANEURYSM | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANTERIOR CHAMBER CELL | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ANTERIOR CHAMBER FLARE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| BLEPHARITIS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CATARACT CORTICAL | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CATARACT NUCLEAR | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHOROIDAL DETACHMENT | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHOROIDAL NEOVASCULARISATION | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL BLEB | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL HYPERAEMIA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CONJUNCTIVAL OEDEMA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CORNEAL OEDEMA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DERMATOCHALASIS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| EYE DISCHARGE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| EYE IRRITATION | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| EYELIDS PRURITUS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| FOREIGN BODY SENSATION IN EYES | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| IRIDOCYCLITIS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| IRITIS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| MACULAR DEGENERATION | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| NEOVASCULAR AGE-RELATED MACULAR DEGENERATION | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| POSTERIOR CAPSULE OPACIFICATION | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| PUNCTATE KERATITIS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| RETINAL HAEMORRHAGE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VITREOUS DETACHMENT | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VITREOUS DISORDER | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VITREOUS FLOATERS | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| VITREOUS HAEMORRHAGE | Eye disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| HORDEOLUM | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| CORNEAL ABRASION | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPHAEMA | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
| |
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA version 21.1 | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE DECREASED | Investigations | MedDRA version 21.1 | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA version 21.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPERTONIC BLADDER | Renal and urinary disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2018 | Feb 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Ranibizumab PD All Participants | Participants had the Implant (prefilled with approximately 20 μL either the 10 mg/mL [approximately 0.2 mg dose], 40 mg/mL [approximately 0.8 mg dose], or 100 mg/mL formulation [approximately 2-mg dose] of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10 mg/mL, 40 mg/mL, or 100 mg/mL formulations of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG004 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
|
| OG002 | Port Delivery System With Ranibizumab 100mg/mL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG003 | Ranibizumab PD All Participants | Participants had the Implant (prefilled with approximately 20 μL either the 10 mg/mL [approximately 0.2 mg dose], 40 mg/mL [approximately 0.8 mg dose], or 100 mg/mL formulation [approximately 2-mg dose] of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10 mg/mL, 40 mg/mL, or 100 mg/mL formulations of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| OG004 | Intravitreal Injection With Ranibizumab 0.5mg | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
|
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