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Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

NCT ID: NCT00989989

Last Updated: 2012-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).

Detailed Description

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Conditions

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Diabetic Macular Edema

Keywords

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DME Diabetic macula edema ranibizumab REVEAL

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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Adjunctive treatment

Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.

Laser photocoagulation

Intervention Type PROCEDURE

Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.

Monotherapy treatment

Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.

Sham laser photocoagulation

Intervention Type PROCEDURE

Sham laser treatment administered at day 1.

Laser control

Active laser treatment plus sham intravitreal injections.

Group Type ACTIVE_COMPARATOR

Laser photocoagulation

Intervention Type PROCEDURE

Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.

Sham ranibizumab

Intervention Type DRUG

Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.

Interventions

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Ranibizumab

Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.

Intervention Type DRUG

Laser photocoagulation

Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.

Intervention Type PROCEDURE

Sham ranibizumab

Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.

Intervention Type DRUG

Sham laser photocoagulation

Sham laser treatment administered at day 1.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with Type 1 or Type 2 diabetes mellitus according to American Diabetes Association (ADA) or World Health Organization (WHO) guidelines with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
* Patients with visual impairment due to focal or diffuse Diabetic Macular Edema in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
* The study eye must fulfill the following criteria at Visit 1:

* Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively, using Early Treatment of Diabetic Retinopathy (ETDRS) chart-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160).
* Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
* Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.

Exclusion Criteria

* Ocular concomitant conditions/ diseases:

* Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.
* Active intraocular inflammation in either eye.
* Any active infection in either eye.
* History of uveitis in either eye.
* Uncontrolled glaucoma in either eye.
* Ocular treatments:

* Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study.
* Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry.
* Systemic conditions or treatments:

* History of stroke
* Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine level \> 2.0 mg/dL.
* Untreated diabetes mellitus
* Blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg
* Compliance/ Administrative:

* Pregnant or nursing (lactating) women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

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

Locations

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Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Changsha, , China

Site Status

Novartis Investigative Site

Chengdu, , China

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Novartis Investigative Site

Chongqing, , China

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Novartis Investigative Site

Guangzhou, , China

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Novartis Investigative Site

Hangzhou, , China

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Novartis Investigational Site

Shanghai, , China

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Novartis Investigative Site

Wenzhou, , China

Site Status

Novartis Investigative Site

Xi'an, , China

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Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Chiba, , Japan

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Novartis Investigative Site

Chiyoda-ku, , Japan

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Novartis Investigative Site

Chūōku, , Japan

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Novartis Investigative Site

Fukuoka, , Japan

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Fukushima, , Japan

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Hirakata, , Japan

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Kita-gun, , Japan

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Kobe, , Japan

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Kyoto, , Japan

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Mitaka, , Japan

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Nagoya, , Japan

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Osaka, , Japan

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Ōtsu, , Japan

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Shimotsuke, , Japan

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Shinjuku-ku, , Japan

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Suita, , Japan

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Toyko, , Japan

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Urayasu, , Japan

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Novartis Investigative Site

Wakayama, , Japan

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Novartis Investigative Site

Yamagata, , Japan

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Novartis Investigative Site

Singapore, , Singapore

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Novartis Investigative Site

Seoul, , South Korea

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Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status

Novartis Investigative Site

Linkou District, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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China Hong Kong Japan Singapore South Korea Taiwan

Other Identifiers

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CRFB002D2303

Identifier Type: -

Identifier Source: org_study_id