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NCT00769015 · ClinicalTrials.gov registry record · Phase 3
Low Vision Depression Prevention Trial for Age Related Macular Degeneration
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT00769015: Completed Phase 3 study, sponsored by Thomas Jefferson University.
NCT00769015 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00769015, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.
Primary Outcome
The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. \< 20/100), baseline better eye scotoma size, baseline depression scores \
Interventions
- BEHAVIORAL BA-LVR
- BEHAVIORAL ST-LVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT00769015 record still lists
NCT00769015 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which BA-LVR is the first listed.
NCT00769015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00769015 about?
NCT00769015 is a clinical study titled "Low Vision Depression Prevention Trial for Age Related Macular Degeneration". This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupationa...
What is the current status of trial NCT00769015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2009-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00769015?
The interventions under investigation include: BA-LVR (BEHAVIORAL), ST-LVR (BEHAVIORAL).
Who is sponsoring clinical trial NCT00769015?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00769015's enrollment target sits among peer trials
188 1408th of 2000 higher than 591 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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