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

NCT00901186 | Completed Phase 2 Results

• 2 other identifiers: CRFB002DES012009-010825-37
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 17

Brief Summary

This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.

Conditions

Diabetic Macular Edema; Visual Impairment

Keywords

Diabetic Macular Edema; Ranibizumab; Laser Treatment; Visual impairment

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)

  Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.

  Baseline, 12 months

Secondary Outcomes (5)

• Percentage of Participants With Improvement in BCVA

  12 months

• Evolution of Mean Change From Baseline in BCVA by Study Visit

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.

  12 months

• Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Percentage of CRT Change From Baseline by Study Visit

  Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Study Arms (2)

RFB002

EXPERIMENTAL

RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.

Drug: RFB002

Laser photocoagulation

ACTIVE COMPARATOR

At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.

Procedure: Laser photocoagulation

Interventions

RFB002 DRUG

0.5 mg

Also known as: Ranibizumab

RFB002

Laser photocoagulation PROCEDURE

Laser photocoagulation

Eligibility Criteria

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

You may qualify if:

• Diabetes mellitus 1 or 2, HbA1c \< 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
• Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
• Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
• Central foveal thickness \>250µm (Optical Coherence Tomography).
• Diabetes medication stable in the 3 months prior.

You may not qualify if:

• In the study eye:
• Active intraocular inflammation.
• Any active infection.
• History of uveitis.
• Structural damage within 500 microns of the center of the macula.
• Neovascularization of the iris.
• Uncontrolled glaucoma in either eye (Intraocular Pressure \> 24 mmHg).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Almería, Andalusia, 04009, Spain

Location

Novartis Investigative Site

Cadiz, Andalusia, 11009, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Mallorca, Balearic Islands, 07198, Spain

Location

Novartis Investigative Site

Barcelona, Barcelona, 08021, Spain

Location

Novartis Investigative Site

Barcelona, Barcelona, 08025, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Novartis Investigative Site

Barakaldo, Basque Country, 48903, Spain

Location

Novartis Investigative Site

Valladolid, Castille and León, 47011, Spain

Location

Novartis Investigative Site

Terrassa, Catalonia, 08221, Spain

Location

Novartis Investigative Site

Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016, Spain

Location

Novartis Investigative Site

San Cristóbal de La Laguna, Las Palmas de Gran Canaria, 38320, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28035, Spain

Location

Novartis Investigative Site

Madrid, Madrid, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31080, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Madrid, 28002, Spain

Location

MeSH Terms

Conditions

Vision Disorders

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

1-862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmaceuticals

  Novartis

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 3, 2017
• Results First Posted: July 3, 2014

Record last verified: 2014-07

Locations

ES (17)