Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

Pigment Epithelial Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976222
• Other study ID #: AMD-PED 08
• Secondary ID: Eudra-CT: 2008-0
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2009
• Last updated: September 27, 2017
• Start date: December 2008
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Pigment Epithelial Detachment
• Retinal Detachment

Intervention

Drug:
• intravitreal injection with ranibizumab
0.5 mg in 0.05 ml, monthly, 12 months

Locations

Country	Name	City	State
Germany	University Hospital Muenchen	Muenchen
Germany	University Hospital Muenster	Muenster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration		12 months
Secondary	Safety		12 months
Secondary	Mean change in best corrected visual acuity		12 months
Secondary	Change in retinal thickness and height of pigment epithelial detachment		12 months
Secondary	Central visual field and stability of fixation		12 months
Secondary	Fluorescein leakage and changes in autofluorescence		12 months