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Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

NCT ID: NCT01122511

Last Updated: 2012-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-05-31

Brief Summary

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This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

Detailed Description

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Conditions

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Subfoveal Choroidal Neovascularization Age-Related Maculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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700 ug dexamethasone and ranibizumab

Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye

Group Type EXPERIMENTAL

700 ug dexamethasone

Intervention Type DRUG

Intravitreal injection of 700 ug dexamethasone into study eye

ranibizumab

Intervention Type BIOLOGICAL

Intravitreal injection of ranibizumab into study eye

ranibizumab and sham

Intravitreal injection of ranibizumab and Sham into study eye

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type BIOLOGICAL

Intravitreal injection of ranibizumab into study eye

sham

Intervention Type OTHER

Sham needle-less injection administered in the study eye

Interventions

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700 ug dexamethasone

Intravitreal injection of 700 ug dexamethasone into study eye

Intervention Type DRUG

ranibizumab

Intravitreal injection of ranibizumab into study eye

Intervention Type BIOLOGICAL

sham

Sham needle-less injection administered in the study eye

Intervention Type OTHER

Other Intervention Names

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OZURDEX® Lucentis®

Eligibility Criteria

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Inclusion Criteria

* Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
* Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
* Visual acuity between 20/320 and 20/40

Exclusion Criteria

* Active ocular infection
* Contraindication to pupil dilation in either eye
* Eye surgery including cataract surgery and/or laser of any type within 3 months
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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Fort Myers, Florida, United States

Site Status

Abilene, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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206207-021

Identifier Type: -

Identifier Source: org_study_id