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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema

Conditions
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Diabetic Macular Edema, Visual Impairment

Intervention / Treatment
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* Drug: RFB002
* Procedure: Laser photocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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). Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFB002<br>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<br>* 0.5 mg<br>* Other names: Ranibizumab;|
| Active Comparator: Laser photocoagulation<br>At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4. | Procedure: Laser photocoagulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Improvement in 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. | 12 months | 
| Evolution of Mean Change From Baseline in BCVA by Study Visit | 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, 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. | VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. | 12 months | 
| Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit | CRT was assessed by Optical Coherence Tomography (OCT). | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 
| Percentage of CRT Change From Baseline by Study Visit | CRT was assessed by Optical Coherence Tomography (OCT). | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Macular Edema, Ranibizumab, Laser Treatment, Visual impairment