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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Bonn, Department of Ophthalmology
  • University of München (LMU), Department of Ophthalmology
  • Universityof Münster, Department of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected Visual Acuity
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol

Secondary Outcome Measures

Retinal Morphology
Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
Vision-related Quality of Life
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.

Full Information

First Posted
July 28, 2013
Last Updated
July 3, 2019
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT01914159
Brief Title
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
Acronym
RIP
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Intervention Description
Monthly intravitreal injections
Primary Outcome Measure Information:
Title
Best-corrected Visual Acuity
Description
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Retinal Morphology
Description
Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
Time Frame
12 months
Title
Vision-related Quality of Life
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Bonn, Department of Ophthalmology
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
University of München (LMU), Department of Ophthalmology
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universityof Münster, Department of Ophthalmology
City
Münster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

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

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