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NCT02510794 · ClinicalTrials.gov registry record · Phase 2
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
NCT02510794: Completed Phase 2 study, sponsored by Genentech.
NCT02510794 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 225 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02510794, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Protocol-Defined Refill Criteria At 1 month after initial fill: * Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: * Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the la
Interventions
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2015-09-28 |
| Est. Completion | 2019-03-28 |
| Phase | Phase 2 |
What the finished NCT02510794 record still lists
NCT02510794 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% higher).
The record links to 0 conditions, and to 1 intervention - of which Ranibizumab is the first listed.
NCT02510794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02510794 about?
NCT02510794 is a clinical study titled "Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration". 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) compare...
What is the current status of trial NCT02510794?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2015-09-28. Estimated completion is 2019-03-28.
What interventions are being tested in trial NCT02510794?
The interventions under investigation include: Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT02510794?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02510794's enrollment target sits among peer trials
225 267th of 2000 higher than 1,732 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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