CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 188 enrolled
Drug / intervention
BA-LVR +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00769015
NCT00769015Phase 3Completed

Low Vision Depression Prevention Trial for Age Related Macular Degeneration

Thomas Jefferson University·interventional·Posted Oct 8, 2008·Updated Nov 20, 2014

In Brief

A Phase 3 clinical trial evaluating BA-LVR and ST-LVR for Age-related Macular Degeneration and Depression. Completed, enrolled 188 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2008
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.7 years ago

Interventions

BA-LVRbehavioral

Low vision clinic-based optometry plus 6 in-home occupational therapy visits

ST-LVRbehavioral

Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy