Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy

Part of paid clinical trials in Royal Oak, Michigan.

Sponsor
Vision Research Foundation
Study ID
NCT01256632
Status
Completed

Conditions

  • Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ranibizumab — DRUG
    All study eyes will receive 0.5mg, of intravitreous monthly injections of ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after.

Study Details

The primary objective: \*To measure the difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative group. Secondary Objective: * To measure the mean change in visual acuity from Baseline to Month 12. * To measure the mean change in central retinal thickness per OCT from Baseline to Month 12

Key Dates

First listed
Dec 8, 2010
Start date
Oct 31, 2007
Status verified
Jun 2012
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP

Arms

  • Active Comparator: Subfoveal CNV, secondary to AMD with PVD
    20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, with Posterior Vitreous Detachment (PVD Positive). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after.
  • Active Comparator: Subfoveal CNV, secondary to AMD w/o PVD
    20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, without Posterior Vitreous Detachment (PVD Negative). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria.

Primary Outcome Measure

Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vision Research FoundationRoyal OakMichigan48073-

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