Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Sham injection
* Procedure: Laser Photocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older with diabetic macular edema Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) Visual acuity in other eye no worse than 20/200 Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months History of glaucoma or current high eye pressure requiring more than 1 medication Uncontrolled systemic disease Known steroid-responder Use of systemic steroids - Use of Warfarin/Heparin

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 700 µg Dexamethasone Implant and Laser Photocoagulation<br>Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. | Drug: Dexamethasone<br>* Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.<br>* Other names: Posurdex®;Procedure: Laser Photocoagulation<br>* Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.<br>|
| Sham Comparator: Sham Implant and Laser Photocoagulation<br>Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. | Drug: Sham injection<br>* Initial sham injection with up to 1 additional treatment based on re-treatment criteria.<br>Procedure: Laser Photocoagulation<br>* Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in BCVA in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Month 12 | 
| Change From Baseline in Central Subfield Retinal Thickness in the Study Eye | Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Month 12 | 
| Change From Baseline in the Focal Leakage Area in the Study Eye | Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Baseline, Month 12 | 
| Time to Retreatment in the Study Eye | Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication. | 12 Months |