Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration

Conditions
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Pigment Epithelial Detachment

Intervention / Treatment
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* Drug: intravitreal injection with ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 Arm Ranibizumab<br> | Drug: intravitreal injection with ranibizumab<br>* 0.5 mg in 0.05 ml, monthly, 12 months<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 12 months | 
| Mean change in best corrected visual acuity |  | 12 months | 
| Change in retinal thickness and height of pigment epithelial detachment |  | 12 months | 
| Central visual field and stability of fixation |  | 12 months | 
| Fluorescein leakage and changes in autofluorescence |  | 12 months |