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Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments

NCT ID: NCT00976222

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Pigment Epithelial Detachment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Arm Ranibizumab

Group Type OTHER

intravitreal injection with ranibizumab

Intervention Type DRUG

0.5 mg in 0.05 ml, monthly, 12 months

Interventions

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intravitreal injection with ranibizumab

0.5 mg in 0.05 ml, monthly, 12 months

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Nicole Eter

Director of Ophthalmology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Eter, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Ophthalmology, University of Muenster Medical Center

Locations

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University Hospital Muenchen

München, , Germany

Site Status

University Hospital Muenster

Münster, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 28084038 (View on PubMed)

Other Identifiers

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Eudra-CT: 2008-004675-22

Identifier Type: -

Identifier Source: secondary_id

AMD-PED 08

Identifier Type: -

Identifier Source: org_study_id