Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||This is an Open Label Study to Evaluate the Efficacy of Intravitreal Aflibercept Injection 2mg in Patients With a Persistent FVPED Despite at Least 6 Consecutive Injections With Ranibizumab 0.5 mg|
- Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) [ Time Frame: 24 weeks is the primary end point of the study ] [ Designated as safety issue: No ]
- Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters. [ Time Frame: 24 weeks is the primary end point of the study ] [ Designated as safety issue: No ]
- Proportion of patients losing ≤ 15 ETDRS letters compared to baseline.
- Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline.
- Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT
|Study Start Date:||December 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
intravitreal aflibercept injection 2mg
This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.
Patients being evaluated at VRM New York with neovascular AMD who have persistent sub-foveal FVPED on OCT despite at least 6 consecutive ranibizumab injections will be considered for the study.
We aim to recruit 25 patients in the study. There have been no statistical tests to calculate sample size; sample size of 25 patients is chosen, making sure that it is feasible financially to conduct the study and logistically to complete the study within 24 weeks. This is a pilot study to assess the effects of intravitreal aflibercept injection on chronic, persistent FVPEDs; currently there is no data regarding visual and anatomical outcomes for this group of patients.
Patients will be reviewed at baseline and then at 4 week intervals (28 ± 7 days). They will receive intravitreal intravitreal aflibercept injection 2mg at each visit. The primary end point of the study is 24 weeks from baseline. Patients who complete the study will have received 6 injections of intravitreal aflibercept injection 2mg.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495208
|United States, New York|
|Vitreous Retina Macula Consultants of New York|
|New York, New York, United States, 10022|
|Principal Investigator:||Richard Spaide, MD||Vitreous -Retina- Macula Consultants of New York|