Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

Phase 4

Completed

• Conditions: Pigment Epithelial Detachment
• Interventions: Drug: intravitreal injection with ranibizumab

• Registration Number: NCT00976222
• Lead Sponsor: University Hospital Muenster

Brief Summary

The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).

Detailed Description

Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a special entity in AMD. As yet, no standard treatment has been established for this disease.The stimuli that induce PED are not very well known, but there is evidence suggesting that angiogenic factors such as vascular endothelial growth factor (VEGF) also play a role in the pathogenesis. Ranibizumab is an anti-VEGF antibody fragment that blocks VEGF activity in patients with neovascular AMD.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
• patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
• patients with pigment epithelial detachment (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

Exclusion Criteria

• patients with best-corrected visual acuity (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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 Arm Ranibizumab	intravitreal injection with ranibizumab	-

Primary Outcome Measures

Name	Time	Method
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration	12 months

Secondary Outcome Measures

Name	Time	Method
Central visual field and stability of fixation	12 months
Fluorescein leakage and changes in autofluorescence	12 months
Change in retinal thickness and height of pigment epithelial detachment	12 months
Mean change in best corrected visual acuity	12 months
Safety	12 months

Trial Locations

Locations (2)

University Hospital Muenchen; 🇩🇪 Muenchen, Germany

University Hospital Muenster; 🇩🇪 Muenster, Germany