Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study

Phase 2

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)

• Registration Number: NCT01914159
• Lead Sponsor: University Hospital, Bonn

Brief Summary

The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-07-28
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2019-04-16
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Results First Posted: 2019-08-15
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
• Written informed consent

Exclusion Criteria

• Time of diagnosis more than 6 months before study recruitment
• Ocular surgery of the study eye within 1 month before study recruitment
• Extensive subretinal fibrosis or retinal atrophy of the study eye
• Significant opacification of optical media of the study eye
• Uncontrolled glaucoma of the study eye
• Active ocular inflammation of the study eye
• Best-corrected visual acuity of the contralateral eye below 20/200
• Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)	-

Primary Outcome Measures

Name	Time	Method
Best-corrected Visual Acuity	12 months	Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol

Secondary Outcome Measures

Name	Time	Method
Vision-related Quality of Life	12 months	National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25); 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst; Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.
Retinal Morphology	12 months	Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness

Trial Locations

Locations (3)

University of Bonn, Department of Ophthalmology; 🇩🇪 Bonn, Germany

University of München (LMU), Department of Ophthalmology; 🇩🇪 München, Germany

Universityof Münster, Department of Ophthalmology; 🇩🇪 Münster, Germany