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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00989989
Other study ID # CRFB002D2303
Secondary ID
Status Completed
Phase Phase 3
First received October 2, 2009
Last updated September 18, 2012
Start date September 2009
Est. completion date August 2011

Study information

Verified date September 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority China: Ministry of HealthChina: Food and Drug AdministrationSingapore: Clinical Trials & Epidemiology Research Unit (CTERU)Japan: Foundation for Biomedical Research and InnovationJapan: Institutional Review BoardJapan: Ministry of Education, Culture, Sports, Science and TechnologyJapan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices AgencyHong Kong: Department of HealthTaiwan: Department of HealthKorea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 396
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.
Procedure:
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.
Drug:
Sham ranibizumab
Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.
Procedure:
Sham laser photocoagulation
Sham laser treatment administered at day 1.

Locations

Country Name City State
China Novartis Investigative Site Beijing
China Novartis Investigative Site Changsha
China Novartis Investigative Site Chengdu
China Novartis Investigative Site Chongqing
China Novartis Investigative Site Guangzhou
China Novartis Investigative Site Hangzhou
China Novartis Investigational Site Shanghai
China Novartis Investigative Site Wenzhou
China Novartis Investigative Site Xi'an
Hong Kong Novartis Investigative Site Hong Kong
Japan Novartis Investigative Site Chiba
Japan Novartis Investigative Site Chiyoda-ku
Japan Novartis Investigative Site Chuo-ku
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Fukushima
Japan Novartis Investigative Site Hirakata
Japan Novartis Investigative Site Kita-gun
Japan Novartis Investigative Site Kobe
Japan Novartis Investigative Site Kyoto
Japan Novartis Investigative Site Mitaka
Japan Novartis Investigative Site Nagoya
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Otsu
Japan Novartis Investigative Site Shimotsuke
Japan Novartis Investigative Site Shinjuku-ku
Japan Novartis Investigative Site Suita
Japan Novartis Investigative Site Toyko
Japan Novartis Investigative Site Urayasu
Japan Novartis Investigative Site Wakayama
Japan Novartis Investigative Site Yamagata
Korea, Republic of Novartis Investigative Site Seoul
Singapore Novartis Investigative Site Singapore
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site LinKou
Taiwan Novartis Investigative Site Taipei

Sponsors (1)

Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

China,  Hong Kong,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement. 12 months No
Secondary Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12 Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement. 12 months No
Secondary Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement. Up to 12 months No
Secondary Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement. Up to 12 months No
Secondary Percent of Participants With Visual Acuity Above 73 Letters at Month 12 Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome. 12 months No
Secondary Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. 12 months No
Secondary Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening. 12 months No
Secondary Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement. 12 months No
Secondary Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening. 12 months No
Secondary Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12 Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. 12 months No
Secondary Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D) The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0). 12 months No
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