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Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

NCT ID: NCT01131585

Last Updated: 2012-08-30

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

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-07-31

Brief Summary

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This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Detailed Description

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Conditions

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Visual Impairment Due to Diabetic Macular Edema

Keywords

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Diabetic macular edema DME Proliferative diabetic retinopathy PDR ranibizumab laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active laser photocoagulation and ranibizumab

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Group Type EXPERIMENTAL

Active laser photocoagulation

Intervention Type PROCEDURE

Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Ranibizumab 0.5 mg

Intervention Type DRUG

Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Active laser photocoagulation and sham injection

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Group Type ACTIVE_COMPARATOR

Active laser photocoagulation

Intervention Type PROCEDURE

Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham injections

Intervention Type DRUG

Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Interventions

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Active laser photocoagulation

Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Intervention Type PROCEDURE

Sham injections

Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Intervention Type DRUG

Ranibizumab 0.5 mg

Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Visual acuity impairment caused by macular edema in at least one eye
* Type 1 or type 2 diabetes mellitus
* Stable medication of diabetes in past 3 month

Exclusion Criteria

* Patients with uncontrolled systemic or ocular diseases
* Laser photocoagulation in the study eye for the last 3 months
* Any history of any intraocular surgery in the study eye within the past 3 months
* Blood pressure \> 160/100 mmHg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Aschaffenburg, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Bonn, , Germany

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Bremen, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Dessau, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Eichstätt, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Giessen, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Karlsruhe, , Germany

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Kiel, , Germany

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Landshut, , Germany

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Leipzig, , Germany

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Marburg, , Germany

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Mühlheim, , Germany

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München, , Germany

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Münster, , Germany

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Nuremberg, , Germany

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Postdam, , Germany

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Recklinghausen, , Germany

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Regensburg, , Germany

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Rosenheim, , Germany

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Siegburg, , Germany

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Novartis Investigative Site

Stuttgart, , Germany

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Novartis Investigative Site

Ulm, , Germany

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Novartis Investigative Site

Würzburg, , Germany

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Countries

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Germany

Related Links

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http://www.NovartisClinicalTrials.com

Click here for more information about this study:

Other Identifiers

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2010-018852-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRFB002DDE13

Identifier Type: -

Identifier Source: org_study_id