Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01535261 | Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion | PHASE3 | COMPLETED | 357 | — | — | Feb 1, 2012 | Mar 1, 2015 | Oct 27, 2016 | 78 | Australia, Austria +16 |
| NCT00942864 | Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO) | PHASE3 | COMPLETED | 40 | — | — | Dec 1, 2008 | Dec 1, 2009 | Sep 29, 2016 | 1 | South Korea |
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
| Arm | Type | Description |
|---|---|---|
| Ranibizumab arm | EXPERIMENTAL | Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN |
| Name | Type | Description |
|---|---|---|
| Ranibizumab 0.5 mg/0.05 ml | DRUG | Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion. |
| ranibizumab | DRUG | ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor |
Inclusion Criteria: * Male or female patients ≥ 18 years of age * Diagnosis of visual impairment exclusively due to ME secondary to CRVO * BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equiva...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
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| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
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