Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-30 @ 2:56 PM
Study NCT ID:
NCT01256632
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2010-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy
Sponsor:
Vision Research Foundation
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PVD
Brief 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
\*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
Detailed Description:
This is an open-label study, of intravitreally administered Ranibizumab in eyes with Age-related Macular Degeneration (AMD), specifically looking at the correlation between the presence of Posterior Vitreous Detachment(PVD) and the number of intravitreal injections of Ranibizumab required. 40 subjects from the offices of Vision Research Foundation will be enrolled in this study. Subjects will be assigned to either a Posterior Vitreous Detachment (PVD) positive group or a Posterior Vitreous Detachment (PVD) negative group based on a pre-treatment ultrasound. A maximum of 20 subjects in each group will be enrolled. Subject accrual into the trial is expected to be completed within 6 months.
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. Eyes will be evaluated with a full ocular examination, visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos, B-scan Ultrasound and subject adverse event monitoring.
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. Eyes will be evaluated with a full ocular examination, visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos, B-scan Ultrasound and subject adverse event monitoring.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: