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Completed

NCT Number: NCT00976222

Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

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).

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Key information

Conditions

Pigment Epithelial Detachment Eye Diseases Retinal Detachment Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Muenchen, München, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravitreal injection with ranibizumab

Drug

0.5 mg in 0.05 ml, monthly, 12 months

Other names: Lucentis

Primary outcomes

  1. To investigate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration

    Time frame: 12 months

Secondary outcomes

  1. Safety

    Time frame: 12 months

  2. Mean change in best corrected visual acuity

    Time frame: 12 months

  3. Change in retinal thickness and height of pigment epithelial detachment

    Time frame: 12 months

  4. Central visual field and stability of fixation

    Time frame: 12 months

  5. Fluorescein leakage and changes in autofluorescence

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Sep 14, 2009
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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