Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study
RIP
1 other identifier
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2013
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 28, 2013
CompletedFirst Posted
Study publicly available on registry
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
August 15, 2019
CompletedAugust 15, 2019
July 1, 2019
3.1 years
July 28, 2013
April 16, 2019
July 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Best-corrected Visual Acuity
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
12 months
Secondary Outcomes (2)
Retinal Morphology
12 months
Vision-related Quality of Life
12 months
Study Arms (1)
Ranibizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Bonn, Department of Ophthalmology
Bonn, 53127, Germany
University of München (LMU), Department of Ophthalmology
München, 80336, Germany
Universityof Münster, Department of Ophthalmology
Münster, 48149, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tim U. Krohne, MD, FEBO
- Organization
- Dept of Ophthalmology, University of Bonn, Bonn, Germany
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Ophthalmology, University of Bonn
Study Record Dates
First Submitted
July 28, 2013
First Posted
August 1, 2013
Study Start
February 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 15, 2019
Results First Posted
August 15, 2019
Record last verified: 2019-07