Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)

NCT ID: NCT00511706

Last Updated: 2019-04-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-01

Study Completion Date

2009-03-01

Brief Summary

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The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Detailed Description

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Conditions

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Choroidal Neovascularization Age-Related Maculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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dexamethasone and ranibizumab

Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

Intravitreal injection of dexamethasone 700 µg at Day 1.

ranibizumab

Intervention Type BIOLOGICAL

Ranibizumab 500 µg at day -30 and Day 7-14.

sham and ranibizumab

Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.

Group Type SHAM_COMPARATOR

ranibizumab

Intervention Type BIOLOGICAL

Ranibizumab 500 µg at day -30 and Day 7-14.

sham

Intervention Type OTHER

Sham needle-less injection administered in the study eye at Day 1.

Interventions

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dexamethasone

Intravitreal injection of dexamethasone 700 µg at Day 1.

Intervention Type DRUG

ranibizumab

Ranibizumab 500 µg at day -30 and Day 7-14.

Intervention Type BIOLOGICAL

sham

Sham needle-less injection administered in the study eye at Day 1.

Intervention Type OTHER

Other Intervention Names

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Posurdex Lucentis®

Eligibility Criteria

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Inclusion Criteria

* 50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
* Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria

* Any intraocular surgery within 3 months
* Glaucoma
* Cataract
* High eye pressure
* Uncontrolled systemic disease
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Boynton Beach, Florida, United States

Site Status

Parramatta, New South Wales, Australia

Site Status

Paris, , France

Site Status

Tel Aviv, , Israel

Site Status

Milan, , Italy

Site Status

Auckland, , New Zealand

Site Status

Coimbra, , Portugal

Site Status

Seoul, , South Korea

Site Status

Southampton, Hampshire, United Kingdom

Site Status

Countries

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United States Australia France Israel Italy New Zealand Portugal South Korea United Kingdom

References

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Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex(R) ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.

Reference Type BACKGROUND
PMID: 26088793 (View on PubMed)

Other Identifiers

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206207-016

Identifier Type: -

Identifier Source: org_study_id

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