Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

NCT00976222 | Completed Phase 4

• 2 other identifiers: AMD-PED 08Eudra-CT: 2008-004675-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Pigment Epithelial Detachment

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (5)

• 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

Study Arms (1)

1 Arm Ranibizumab

OTHER

Drug: intravitreal injection with ranibizumab

Interventions

intravitreal injection with ranibizumab DRUG

0.5 mg in 0.05 ml, monthly, 12 months

Also known as: Lucentis

1 Arm Ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Novartis: collaborator

Study Sites (2)

University Hospital Muenchen

München, 80336, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

Related Publications (1)

• Clemens CR, Wolf A, Alten F, Milojcic C, Heiduschka P, Eter N. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study. Acta Ophthalmol. 2017 Nov;95(7):683-689. doi: 10.1111/aos.13359. Epub 2017 Jan 13.

  PMID: 28084038 DERIVED

MeSH Terms

Conditions

Retinal Detachment

Interventions

Intravitreal Injections; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nicole Eter, MD

  Dept. of Ophthalmology, University of Muenster Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Ophthalmology Department

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

DE (2)