Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nicole Eter, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00976222
First received: September 11, 2009
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Pigment Epithelial Detachment
Drug: intravitreal injection with ranibizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Mean change in best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in retinal thickness and height of pigment epithelial detachment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Central visual field and stability of fixation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fluorescein leakage and changes in autofluorescence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: intravitreal injection with ranibizumab
    0.5 mg in 0.05 ml, monthly, 12 months
    Other Name: Lucentis
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976222

Locations
Germany
University Hospital Muenchen
Muenchen, Germany, 80336
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital, Bonn
Novartis
Investigators
Principal Investigator: Nicole Eter, MD Dept. of Ophthalmology, University of Muenster Medical Center
  More Information

No publications provided

Responsible Party: Nicole Eter, Director of Ophthalmology Department, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00976222     History of Changes
Other Study ID Numbers: AMD-PED 08, Eudra-CT: 2008-004675-22
Study First Received: September 11, 2009
Last Updated: January 17, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Macular Degeneration
Retinal Detachment
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014