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This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.
Patients were randomized to the study in 2 treatment groups: ranibizumab + vPDT combination therapy, and ranibizumab monotherapy. Based on the results of the primary analysis at Month 12, patients still in the ranibizumab monotherapy group at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit. A total of 168 and 154 patients were included in the ranibizumab + vPDT combined therapy and ranibizumab monotherapy groups, respectively for the FAS (Month 12 analysis). However, the safety set included 172 and 149 patients, respectively. Four patients in the combination therapy group never took vPDT . Among them, 1 patient actually received verteporfin injection but no laser injection. Thus a total of 3 patients (4-1) in the combination therapy group did not take the actual full vPDT treatment. Additionally, 7 patients in the monotherapy group received vPDT and 1 patient from the monotherapy group did not receive ranibizumab treatment. Considering the above numbers, safety set included 172 patients (i.e., 168-3+7) in the ranibizumab + vPDT combination therapy group and 149 patients (i.e., 154-7+3-1) in the ranibizumab monotherapy group for Month 12 analysis. For the Month 24 safety analysis, the 14 patients in the ranibizumab monotherapy group who were switched to ranibizumab +vPDT combination therapy group were analyzed as a separate group, ie, ranibizumab 0.5 mg + vPDT (switched).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab + vPDT | Experimental | Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) determined at monthly visits based on defined retreatment criteria |
|
| Ranibizumab monotherapy | Active Comparator | Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) determined at monthly visits based on defined retreatment criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injection of 0.5 mg ranibizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. | Baseline, Month 12 |
| Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye | Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hong Kong | Hong Kong | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40504425 | Derived | Yanagi Y, Mori R, Teo KYC, Park KH, Ngah NF, Chen SJ, Ruamviboonsuk P, Kondo N, Lee WK, Rajagopalan R, Obata R, Wong IYH, Chee C, Terasaki H, Sekiryu T, Chen SC, Lai TYY, Cheung G, Honda S. Six-year findings of polypoidal choroidal vasculopathy in the EVEREST II study: Japanese subgroup analysis. Jpn J Ophthalmol. 2025 Nov;69(6):894-901. doi: 10.1007/s10384-025-01228-w. Epub 2025 Jun 12. | |
| 38308746 |
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The enrollment number in the protocol section reflects the number of participants treated (321). The total number in the participant flow and baseline characteristics sections reflects the number of participants randomized (322).
This study was conducted in the following jurisdictions: Japan (25 centers), Malaysia (2 centers), Singapore (4 centers), Hong Kong (2 centers), Taiwan (6 centers), Thailand (3 centers) and Korea (5 centers).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab 0.5 mg + vPDT | Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) |
| FG001 | Ranibizumab 0.5 mg |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Verteporfin PDT | Drug | Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm) |
|
| Sham PDT | Drug | Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm) |
|
| Baseline, Month 24 |
| Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. | Baseline, Month 24 |
| Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption | Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. | Month 3, Month 12, Month 24 |
| Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption | Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. | Month 3, Month 12, Month 24 |
| Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision. | Month 6, Month 24 |
| Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Presence of lesion leakage was based on Fluorescein Angiography (FA) as assessed by the Central Reading Center (CRC). The presence of leakage may lead to disease progression and worsening vision. | Month 6, Month 12 and Month 24 |
| Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. | Baseline, Month 24 |
| Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12 | Baseline, Month 12 |
| Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12 | Baseline, Month 12 |
| Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 | Baseline, Month 24 |
| Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 | Baseline, Month 24 |
| Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12 | Month 3, Month 12 |
| Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 | Month 3, Month 24 |
| Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Months 3, 12 and 24. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function. | Baseline, Month 3, Month 12, Month 24 |
| Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Reported categorically: Mild, Moderate, Severe | Up to Month 24 |
| Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Reported categorically: Mild, Moderate, Severe | Up to Month 24 |
| Nagoya |
| Aichi-ken |
| 462-0825 |
| Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466 8560 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Fukushima | Fukushima | 960-1295 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371 8511 | Japan |
| Novartis Investigative Site | Amagasaki | Hyōgo | 660 8550 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0017 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0047 | Japan |
| Novartis Investigative Site | Inashiki-gun | Ibaraki | 300-0395 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Novartis Investigative Site | Sakyo-ku | Kyoto | 606 8507 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-8507 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-8558 | Japan |
| Novartis Investigative Site | Hirakata | Osaka | 573-1191 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 550-0024 | Japan |
| Novartis Investigative Site | Ohtsu-city | Shiga | 520-2192 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113 8655 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 101-8309 | Japan |
| Novartis Investigative Site | Mitaka | Tokyo | 181-8611 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 162 8666 | Japan |
| Novartis Investigative Site | Chiba | 260-8677 | Japan |
| Novartis Investigative Site | Batu Caves | Selangor | 68100 | Malaysia |
| Novartis Investigative Site | Petaling Jaya | Selangor | 46150 | Malaysia |
| Novartis Investigative Site | Singapore | 119074 | Singapore |
| Novartis Investigative Site | Singapore | 168751 | Singapore |
| Novartis Investigative Site | Singapore | 308433 | Singapore |
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 02447 | South Korea |
| Novartis Investigative Site | Seoul | Seocho-gu | 06591 | South Korea |
| Novartis Investigative Site | Seoul | 07301 | South Korea |
| Novartis Investigative Site | Seoul | 150-950 | South Korea |
| Novartis Investigative Site | Taipei | Taiwan, ROC | 11217 | Taiwan |
| Novartis Investigative Site | Changhua | 50006 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 81346 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 10449 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Derived |
| Teo KYC, Park KH, Ngah NF, Chen SJ, Ruamviboonsuk P, Mori R, Kondo N, Lee WK, Rajagopalan R, Obata R, Wong IYH, Chee C, Terasaki H, Sekiryu T, Chen SC, Yanagi Y, Honda S, Lai TYY, Cheung CMG. Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the EVEREST II Study. Ophthalmol Ther. 2024 Apr;13(4):935-954. doi: 10.1007/s40123-024-00888-0. Epub 2024 Feb 3. |
| 32672800 | Derived | Lim TH, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Lee WK, Cheung CMG, Ngah NF, Patalauskaite R, Margaron P, Koh A; EVEREST II Study Group. Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: The EVEREST II Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):935-942. doi: 10.1001/jamaophthalmol.2020.2443. |
| 28983556 | Derived | Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Feller C, Margaron P, Lim TH, Lee WK; EVEREST II study group. Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1206-1213. doi: 10.1001/jamaophthalmol.2017.4030. |
Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)
| FG002 | Ranibizumab 0.5 mg + vPDT (Switched) | Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit |
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| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab 0.5 mg + vPDT | Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) |
| BG001 | Ranibizumab 0.5 mg | Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) |
| BG002 | Ranibizumab 0.5 mg + vPDT (Switched) | Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data | Posted | Least Squares Mean | Standard Error | Letters | Baseline, Month 12 |
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| Primary | Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye | Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision. | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data | Posted | Number | Participants | Baseline, Month 12 |
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| Secondary | Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. | All patients with a BCVA value for both baseline and Month 24 | Posted | Least Squares Mean | Standard Error | Letters | Baseline, Month 24 |
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| Secondary | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. | All participants with a BCVA value for both Baseline and Month 24. | Posted | Number | Percentage of participants | Baseline, Month 24 |
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| Secondary | Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption | Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. | Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected. | Posted | Month 3, Month 12, Month 24 |
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| Secondary | Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption | Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. | Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected. | Posted | Month 3, Month 12, Month 24 |
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| Secondary | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision. | All patients who attended the specific visit | Posted | Number | Percentage of participants | Month 6, Month 24 |
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| Secondary | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Presence of lesion leakage was based on Fluorescein Angiography (FA) as assessed by the Central Reading Center (CRC). The presence of leakage may lead to disease progression and worsening vision. | All patients who attended the specific visit | Posted | Number | Percentage of participants | Month 6, Month 12 and Month 24 |
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| Secondary | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. | All patients with a value at baseline and at Month 24 | Posted | Least Squares Mean | Standard Error | Micrometers | Baseline, Month 24 |
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| Secondary | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12 | Safety Analysis Set | Posted | Number | injections | Baseline, Month 12 |
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| Secondary | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12 | Safety Analysis Set | Posted | Number | injections | Baseline, Month 12 |
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| Secondary | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 | Safety Analysis Set | Posted | Number | injections | Baseline, Month 24 |
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| Secondary | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 | Safety Analysis Set | Posted | Number | injections | Baseline, Month 24 |
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| Secondary | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12 | Safety Analysis Set | Posted | Number | injections | Month 3, Month 12 |
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| Secondary | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 | Safety Analysis Set | Posted | Number | injections | Month 3, Month 24 |
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| Secondary | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Months 3, 12 and 24. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function. | All patients with a value for both baseline and the specific post-baseline visit. The baseline value is the last available, non-missing, value collected prior to first study treatment in the study eye. | Posted | Least Squares Mean | Standard Deviation | Unit of scales | Baseline, Month 3, Month 12, Month 24 |
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| Secondary | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Reported categorically: Mild, Moderate, Severe | Safety Analysis Set | Posted | Number | Adverse Events | Up to Month 24 |
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| Secondary | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Reported categorically: Mild, Moderate, Severe | Safety Analysis Set | Posted | Number | Adverse Events | Up to Month 24 |
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Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab 0.5 mg + vPDT | Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) | 2 | 172 | 27 | 172 | 80 | 172 |
| EG001 | Ranibizumab 0.5 mg | Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) | 1 | 135 | 23 | 135 | 45 | 135 |
| EG002 | Ranibizumab 0.5 mg + vPDT (Switched) | Ranibizumab 0.5 mg + vPDT (Switched) | 0 | 14 | 2 | 14 | 11 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Blindness unilateral (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cataract (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
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| Cataract (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Macular hole (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ocular hypertension (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Polypoidal choroidal vasculopathy (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Retinal haemorrhage (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vitreous haemorrhage (Fellow treated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Campylobacter colitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Endophthalmitis (Study eye) | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vocal cord leukoplakia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Corneal disorder (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Corneal disorder (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dry eye (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dry eye (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyschromatopsia (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eye irritation (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lacrimation increased (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ocular hyperaemia (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ocular hyperaemia (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ocular hypertension (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Punctate keratitis (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Punctate keratitis (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Retinal haemorrhage (Study eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Retinal vein occlusion (Fellow untreated eye) | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Injection site pain (Study eye) | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Mass | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Foreign body in eye (Fellow untreated eye) | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Foreign body in eye (Study eye) | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Visual field defect (Study eye) | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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
| Male |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
|
Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
| Ranibizumab 0.5 mg + vPDT (Switched) |
Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit |
|
|
| Participants |
|
|
| Participants |
|
|