Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

University Hospital Muenster

Status and phase: Completed; Phase 4

Conditions: Pigment Epithelial Detachment

Treatments: Drug: intravitreal injection with ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00976222

Eudra-CT: 2008-004675-22

AMD-PED 08

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

1 Arm Ranibizumab

Other group

Treatment:

Drug: intravitreal injection with ranibizumab