A Phase 4 interventional study of Aflibercept in Fibrovascular Pigment Epithelial Detachment, sponsored by Vitreous -Retina- Macula Consultants of New York. Withdrawn at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Vitreous -Retina- Macula Consultants of New York · Phase 4, Interventional, and Treatment
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.
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.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
Browse Retinal Detachment studies →Vitreous -Retina- Macula Consultants of New York is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Aflibercept
intravitreal aflibercept injection 2mg
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)
Using the Heidelberg software, subfoveal subretinal fluid (distance between the IS/OS line and the RPE line on SDOCT)
Time frame: 24 weeks is the primary end point of the study
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)
Measure of retinal volume (distance between the ILM and RPE outer margin on SDOCT)
Time frame: 24 weeks is the primary end point of the study
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)
Measure of PED height (distance between ILM and Bruchs membrane (if visible) or the horizontal line where the RPE should be present if it was not elevated)
Time frame: 24 weeks is the primary end point of the study
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)
Measure of maximal diameter of the PED (measured as the point from where the RPE detachment begins to where it ends) will be measured.
Time frame: 24 weeks is the primary end point of the study
Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters.
* Proportion of patients losing ≤ 15 ETDRS letters compared to baseline. * Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline.
Time frame: 24 weeks is the primary end point of the study
Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS
Measure the Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT
Time frame: 24 weeks is the primary end point of the study
This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Vitreous -Retina- Macula Consultants of New York