Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Barnes Retina Institute
Study ID
NCT00831350
Phase
PHASE2
Status
Completed

Conditions

  • Posterior Vitreous Detachment
  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Subjects will receive study medication ranibizumab 0.5mg. Re-treatment will occur monthly through 6 injections

Study Details

This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Posterior vitreous detachment is a condition where the gel-like substance that occupies the space between the retina and the lens of the eye liquefies and separates from the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography to check the thickness of your retina) and clinical exam, subjects will be assigned to one of 2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD. Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.

Key Dates

First listed
Jan 28, 2009
Start date
Apr 30, 2009
Status verified
Oct 2017
Primary completion
Jul 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
32 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ranibizumab

Primary Outcome Measure

Mean change in BCVA at 6 months in the PVD positive and PVD negative ranibizumab-treated groups. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Barnes Retina InstituteSt LouisMissouri63110-

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Barnes Retina Institute· St Louis, MO

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