Intravitreal ranibizumab in patients with retinal pigment epithelial detachments secondary to AMD

Phase 1

• Conditions: Pigment epithelial detachments secondary to age-relatedmacular degeneration; MedDRA version: 9.1Level: LLTClassification code 10064930Term: Age-related macular degeneration

• Registration Number: EUCTR2008-004675-22-DE
• Lead Sponsor: niversity of Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-patients with AMD and serous PED as determined by fluoresceine and indocyaningreen angiography and optical coherence tomography (OCT)
-patients who have a BCVA score between 73 and 24 ETDRS letters
-patients with PED = 200 µm as determined by OCT
-male or female patients 50 years of age or greater
-patients willing and able to comply with all study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-patients with BCVA < 24 or >73 letters in the study eye
-patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
-history of uncontrolled glaucoma in the study eye

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD;Secondary Objective: - to evaluate the safety of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD<br>- to evaluate the effect of ranibizumab on the change in visual function as assessed by the mean change in BCVA from Baseline <br>- to evaluate the effect of ranibizumab on retinal structure as assessed by mean and percent change in retinal thickness and height of PED, as measured by spectral-domain optical coherence tomography<br>- to evaluate the effect of ranibizumab on central visual field and stability of fixation as determined by NIDEK MP-1 microperimetry<br>- to evaluate the effect of ranibizumab as assessed by the incidence of fluorescein leakage and changes in autofluorescence<br>;Primary end point(s): -Best-corrected visual acuity (ETDRS-charts)<br>-PED height (OCT)<br>