Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
Overview
- Phase
- Phase 4
- Intervention
- intravitreal injection with ranibizumab
- Conditions
- Pigment Epithelial Detachment
- Sponsor
- University Hospital Muenster
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Nicole Eter
Director of Ophthalmology Department
University Hospital Muenster
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
Arms & Interventions
1 Arm Ranibizumab
Intervention: intravitreal injection with ranibizumab
Outcomes
Primary Outcomes
To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration
Time Frame: 12 months
Secondary Outcomes
- Mean change in best corrected visual acuity(12 months)
- Central visual field and stability of fixation(12 months)
- Fluorescein leakage and changes in autofluorescence(12 months)
- Safety(12 months)
- Change in retinal thickness and height of pigment epithelial detachment(12 months)