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

July 3, 2019 updated by: Frank G. Holz, University Hospital, Bonn
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • University of Bonn, Department of Ophthalmology
      • München, Germany, 80336
        • University of München (LMU), Department of Ophthalmology
      • Münster, Germany, 48149
        • Universityof Münster, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab
Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Monthly intravitreal injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected Visual Acuity
Time Frame: 12 months
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Morphology
Time Frame: 12 months
Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
12 months
Vision-related Quality of Life
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 28, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-037.0156

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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