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Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nicole Eter, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00976222
First received: September 11, 2009
Last updated: June 1, 2016
Last verified: June 2016

September 11, 2009
June 1, 2016
December 2008
December 2014   (final data collection date for primary outcome measure)
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 ]
To demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to AMD [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00976222 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety [ Time Frame: 12 months ]
  • Mean change in best corrected visual acuity (BCVA) [ Time Frame: 12 months ]
  • Change in retinal thickness and height of PED [ Time Frame: 12 months ]
  • Central visual field and stability of fixation [ Time Frame: 12 months ]
  • Fluorescein leakage and changes in autofluorescence [ Time Frame: 12 months ]
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Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments
Intravitreal Ranibizumab in Patients With Retinal Pigment Epithelial Detachments Secondary to Age-related Macular Degeneration
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).
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.
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pigment Epithelial Detachment
Drug: intravitreal injection with ranibizumab
0.5 mg in 0.05 ml, monthly, 12 months
Other Name: Lucentis
1 Arm Ranibizumab
Intervention: Drug: intravitreal injection with ranibizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00976222
AMD-PED 08, Eudra-CT: 2008-004675-22
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Nicole Eter, University Hospital Muenster
University Hospital, Bonn
Novartis
Principal Investigator: Nicole Eter, MD Dept. of Ophthalmology, University of Muenster Medical Center
University Hospital, Bonn
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP