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

NCT01256632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-06-28

No results posted yet for this study

Summary

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

Conditions

  • Choroidal Neovascularization

Interventions

DRUG

Ranibizumab

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Vision Research Foundation

    lead OTHER

Principal Investigators

  • Michael T Trese, MD · Vision Research Foundation

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256632 on ClinicalTrials.gov