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This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUSVIMO | Experimental | Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres [uL] of the 100 milligrams/millilitres [mg/ml] formulation of ranibizumab [approximately 2 milligrams (mg) dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDS Implant With Ranibizumab 100 mg/ml | Device | Ranibizumab 100 mg/mL will be delivered via PDS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy | Baseline, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye | Baseline, Week 24 | |
| Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye |
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Inclusion Criteria
Ocular Inclusion Criteria:
Diagnosis of nAMD prior to screening as determined by the investigator
Difference of <10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
All subtypes of nAMD lesions are permissible
nAMD lesions at the time of diagnosis must involve the macula
Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images
Exclusion Criteria
Prior Ocular Treatment
Study Eye:
Either Eye:
Macular Neovascularization Lesion (MNV) Characteristics
Study Eye:
Either Eye:
Current or Historical Ocular Conditions
Study Eye:
Fellow (Non-Study) Eye:
• Concurrent or history of PDS implantation
Either Eye:
Concurrent Systemic Conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML43000 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Recruiting | Mesa | Arizona | 85206-2747 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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The BVCA examiner will be masked as best as possible to participant study eye assignment and study visit type.
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| LUCENTIS (Ranibizumab Injection) |
| Drug |
Ranibizumab (0.5 mg intravitreal [IVT] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion. |
|
| Baseline, Week 24, Week 48 |
| Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye | Baseline, Week 24, Week 48 |
| Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs | Day 1 up to approximately Week 52 |
| Percentage of Participants With Ocular Adverse Events of Special Interests (AESIs) and Severity of Ocular AESIs | Day 1 to Week 52 |
| Duration of Ocular AESIs | Day 1 to Week 52 |
| Percentage of Participants With Ocular AESIs During the Postoperative Period | Baseline up to 37 days of initial implantation |
| Percentage of Participants With Ocular AESIs During the Intermediate Postoperative Period | 38 to 93 days after implantation |
| Percentage of Participants With Ocular AESIs During the Follow-up Period | The investigator will follow each adverse event (AE) until the event has resolved to baseline grade or better, the event is assessed as stable by the investigator, the participant is lost to follow-up, or the participant withdraws consent. | Week 52 |
| Percentage of Participants With Adverse Device Effects (ADEs) | Day 1 to Week 52 |
| Number of Participants with Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs | Day 1 to Week 52 |
| Duration of ASADEs | Day 1 to Week 52 |
| California Retina Consultants |
| Completed |
| Bakersfield |
| California |
| 93309 |
| United States |
| Retina Associates of Southern California | Recruiting | Huntington Beach | California | 92647 | United States |
| California Eye Specialists Medical group Inc. | Completed | Pasadena | California | 91107-3747 | United States |
| Retinal Consultants Med Group | Recruiting | Sacramento | California | 95841-2013 | United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94158-2510 | United States |
| Orange County Retina Med Group | Recruiting | Santa Ana | California | 92705-6504 | United States |
| Macula Retina Vitreous Research Institute | Recruiting | Torrance | California | 90503-3270 | United States |
| Southwest Retina Consultants | Completed | Durango | Colorado | 81303 | United States |
| Advanced Vision Research Institute | Recruiting | Longmont | Colorado | 80503-6499 | United States |
| Retina Group of New England | Withdrawn | Waterford | Connecticut | 06385-1215 | United States |
| Retina Specialty Institute | Recruiting | Pensacola | Florida | 32503-2030 | United States |
| Ft Lauderdale Eye Institute | Withdrawn | Plantation | Florida | 33324-3118 | United States |
| Retina Vitreous Associates of Florida | Recruiting | St. Petersburg | Florida | 33711-1141 | United States |
| Southeast Retina Center | Recruiting | Augusta | Georgia | 30909-6440 | United States |
| University Retina and Macula Associates, PC | Recruiting | Lemont | Illinois | 60439-7421 | United States |
| Wolfe Eye Clinic | Withdrawn | West Des Moines | Iowa | 50266 | United States |
| Retina Associates of Kentucky | Withdrawn | Lexington | Kentucky | 40509-1827 | United States |
| Maine Eye Center | Recruiting | Portland | Maine | 04101 | United States |
| The Retina Care Center | Recruiting | Baltimore | Maryland | 21209-2219 | United States |
| Wilmer Eye Institute Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287-0005 | United States |
| Retina Group of Washington | Withdrawn | Chevy Chase | Maryland | 20815-6956 | United States |
| Cumberland Valley Retina Consultants PC | Completed | Hagerstown | Maryland | 21740 | United States |
| Associated Retinal Consultants PC | Recruiting | Royal Oak | Michigan | 48073 | United States |
| VitreoRetinal Surgery, PLLC. | Recruiting | Minneapolis | Minnesota | 55435-3004 | United States |
| Midwest Vision Research Foundation | Completed | Chesterfield | Missouri | 63017-5065 | United States |
| Sierra Eye Associates | Recruiting | Reno | Nevada | 89502-1605 | United States |
| Envision Ocular, LLC | Recruiting | Bloomfield | New Jersey | 07003 | United States |
| Seeta Eye Centers | Recruiting | Poughkeepsie | New York | 12603-2416 | United States |
| Western Carolina Retinal Associate PA | Withdrawn | Asheville | North Carolina | 28803-2493 | United States |
| Duke Eye Center | Recruiting | Durham | North Carolina | 27705-4699 | United States |
| Graystone Eye | Recruiting | Hickory | North Carolina | 28602 | United States |
| Fargo Retina Consultants | Recruiting | Fargo | North Dakota | 58047 | United States |
| Cincinnati Eye Institute | Recruiting | Blue Ash | Ohio | 45242-5537 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| Tulsa Retina Consultants | Withdrawn | Tulsa | Oklahoma | 74114 | United States |
| Erie Retina Research | Completed | Erie | Pennsylvania | 16505 | United States |
| Mid Atlantic Retina | Withdrawn | Philadelphia | Pennsylvania | 19107-5109 | United States |
| Palmetto Retina Center | Withdrawn | Florence | South Carolina | 29501 | United States |
| Palmetto Retina Center, LLC | Withdrawn | West Columbia | South Carolina | 29169-2429 | United States |
| Charles Retina Institute | Recruiting | Germantown | Tennessee | 38138-2405 | United States |
| Tennessee Retina PC | Recruiting | Nashville | Tennessee | 37203-1596 | United States |
| Panhandle Eye Group LLP Southwest Retina Specialists | Completed | Amarillo | Texas | 79106-1835 | United States |
| Austin Retina Associates | Withdrawn | Austin | Texas | 78705-1169 | United States |
| Austin Clinical Research, LLC | Recruiting | Austin | Texas | 78750-2298 | United States |
| Retina Consultants of Texas | Recruiting | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas | Recruiting | Schertz | Texas | 78154 | United States |
| Retina Associates of Utah, PLLC | Recruiting | Salt Lake City | Utah | 84107-6767 | United States |
| Piedmont Eye Center | Recruiting | Lynchburg | Virginia | 24502-4271 | United States |
| Wagner Kapoor Institute | Recruiting | Norfolk | Virginia | 23502-3933 | United States |
| Retina Institute of Virginia | Withdrawn | Richmond | Virginia | 23235-1962 | United States |
| Spokane Eye Clinical Research | Recruiting | Spokane | Washington | 99204 | United States |
| 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 |
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