Clinical trial NCT00976222: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pigment Epithelial Detachment
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2009-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 12 months
measure: Mean change in best corrected visual acuity
timeFrame: 12 months
measure: Change in retinal thickness and height of pigment epithelial detachment
timeFrame: 12 months
measure: Central visual field and stability of fixation
timeFrame: 12 months
measure: Fluorescein leakage and changes in autofluorescence
timeFrame: 12 months
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: University Hospital Muenchen
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: Dept. of Ophthalmology, University of Muenster Medical Center
name: Nicole Eter, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.