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NCT00764738 · ClinicalTrials.gov registry record · Phase 2
Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
A Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Retina Macula Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 1
- Study location
NCT00764738: Completed Phase 2 study of Neovascular Age-related Macular Degeneration, sponsored by Retina Macula Institute.
NCT00764738 is a Phase 2 study of Neovascular Age-related Macular Degeneration that has completed, run by Retina Macula Institute. The registered enrollment target is 91 participants, below the 406-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00764738, a Phase 2 study of Neovascular Age-related Macular Degeneration, has completed, sponsored by Retina Macula Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 1
- Study location
Study Summary
Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.
Primary Outcome
As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).
Conditions Studied
Interventions
- DEVICE OCT, Multifocal ERG, Microperimetry
- DRUG Ranibizumab Ophthalmic
Study Locations (1)
California
- Retina Macula Institute - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00764738 record still lists
NCT00764738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 406-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which OCT, Multifocal ERG, Microperimetry is the first listed.
NCT00764738 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00764738 about?
NCT00764738 is a clinical study titled "Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration". Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA ...
What is the current status of trial NCT00764738?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2008-10. Estimated completion is 2011-11.
What conditions does trial NCT00764738 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT00764738?
The interventions under investigation include: OCT, Multifocal ERG, Microperimetry (DEVICE), Ranibizumab Ophthalmic (DRUG).
Who is sponsoring clinical trial NCT00764738?
This trial is sponsored by Retina Macula Institute, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00764738 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00764738's enrollment target sits among peer trials
91 16th of 33 higher than 18 of 33 other Neovascular Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration 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.
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