A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

NCT02259088 | Completed Phase 3 Results

• 1 other identifier: CRFB002D2305
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 28

Brief Summary

Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

Conditions

Diabetic Macular Edema; Visual Impairment

Keywords

DME; macular edema; vision impairment; Chinese; diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12

  Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.

  Baseline, Monthly from Month 1 through Month 12

Secondary Outcomes (20)

• Mean Change From Baseline in BCVA (Letters) at Each Visit

  Baseline, Monthly from Month 1 through Month 12

• Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit

  Baseline, Monthly from Month 1 through Month 12

• Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12

  Baseline, Month 12

• Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12

  Baseline, Month 12

• Percentage of Patients With BCVA ≥ 73 Letters at Month 12

  Month 12

Study Arms (2)

Ranibizumab (RFB002)

EXPERIMENTAL

3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser

Drug: Ranibizumab (RFB002); Procedure: Sham laser

Laser

ACTIVE COMPARATOR

Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections

Procedure: Laser; Drug: Sham injection

Interventions

Ranibizumab (RFB002) DRUG

Ranibizumab 0.5 mg/0.05 mL for intravitreal injection

Also known as: Lucentis

Ranibizumab (RFB002)

Laser PROCEDURE

Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines

Laser

Sham injection DRUG

Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle

Laser

Sham laser PROCEDURE

Imitation of an active laser

Ranibizumab (RFB002)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
• Stable medication for diabetes within 3 months prior to Visit 1
• Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters

You may not qualify if:

• Stroke or myocardial infarction less than 3 months prior to screening visit
• Uncontrolled hypertension
• Active ocular infection or intraocular inflammation in any eye
• Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
• Active proliferative diabetic retinopathy in study eye
• Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
• Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
• History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Novartis Investigative Site

Beijing, Beijing Municipality, 100044, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100191, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510060, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510632, China

Location

Novartis Investigative Site

Shantou, Guangdong, 515041, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430070, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Wuxi, Jiangsu, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330019, China

Location

Novartis Investigative Site

Qingdao, Shandong, 2666000, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300020, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300070, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310003, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310014, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325027, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Beijing, 100050, China

Location

Novartis Investigative Site

Beijing, 100053, China

Location

Novartis Investigative Site

Beijing, 100176, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Chongqing, 400042, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Novartis Investigative Site

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Vision Disorders; Macular Edema; Diabetes Mellitus

Interventions

Ranibizumab; Lasers; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: November 5, 2014
• Primary Completion: January 17, 2017
• Study Completion: January 17, 2017
• Last Updated: February 1, 2019
• Results First Posted: February 1, 2019

Record last verified: 2019-01

Locations

CN (28)