Back to resultsIntravitreal Ranibizumab in Retinal Pigment Epithelial Detachments
Primary Purpose
Pigment Epithelial Detachment
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
intravitreal injection with ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Pigment Epithelial Detachment
Eligibility Criteria
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
Sites / Locations
- University Hospital Muenchen
- University Hospital Muenster
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1 Arm Ranibizumab
Arm Description
Outcomes
Primary Outcome Measures
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
Secondary Outcome Measures
Safety
Mean change in best corrected visual acuity
Change in retinal thickness and height of pigment epithelial detachment
Central visual field and stability of fixation
Fluorescein leakage and changes in autofluorescence
Full Information
NCT ID
NCT00976222
First Posted
September 11, 2009
Last Updated
September 27, 2017
Sponsor
University Hospital Muenster
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00976222
Brief Title
Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments
Official Title
Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster
Collaborators
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigment Epithelial Detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Arm Ranibizumab
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
intravitreal injection with ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5 mg in 0.05 ml, monthly, 12 months
Primary Outcome Measure Information:
Title
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety
Time Frame
12 months
Title
Mean change in best corrected visual acuity
Time Frame
12 months
Title
Change in retinal thickness and height of pigment epithelial detachment
Time Frame
12 months
Title
Central visual field and stability of fixation
Time Frame
12 months
Title
Fluorescein leakage and changes in autofluorescence
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Eter, MD
Organizational Affiliation
Dept. of Ophthalmology, University of Muenster Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
University Hospital Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28084038
Citation
Clemens CR, Wolf A, Alten F, Milojcic C, Heiduschka P, Eter N. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study. Acta Ophthalmol. 2017 Nov;95(7):683-689. doi: 10.1111/aos.13359. Epub 2017 Jan 13.
Results Reference
derived
Learn more about this trial
Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments
We'll reach out to this number within 24 hrs