Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-06-30

Brief Summary

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This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

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Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Ranibizumab 0.3 mg

Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Group Type EXPERIMENTAL

Ranibizumab 0.3 mg

Intervention Type DRUG

6 mg/ml ranibizumab solution for intravitreal injection

Ranibizumab 0.5 mg

Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Group Type EXPERIMENTAL

Ranibizumab 0.5 mg

Intervention Type DRUG

10 mg/ml ranibizumab solution for intravitreal injection

Sham injection

Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type DRUG

Non-treatment control for sham intravitreal injection.

Interventions

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Ranibizumab 0.3 mg

6 mg/ml ranibizumab solution for intravitreal injection

Intervention Type DRUG

Ranibizumab 0.5 mg

10 mg/ml ranibizumab solution for intravitreal injection

Intervention Type DRUG

Sham injection

Non-treatment control for sham intravitreal injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetic macular edema with center involvement in at least one eye
* Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
* Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion Criteria

* Patients with uncontrolled systemic or ocular diseases
* Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening
* Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No