A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Allergan554 enrolled

Overview

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

554

Conditions

Diabetic Macular Edema

Interventions

DexamethasoneDRUG

350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

ShamOTHER

Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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 Key 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

Locations (14)

Unnamed facility

Artesia, California, United States

Unnamed facility

São Paulo, Brazil

Unnamed facility

Mississauga, Ontario, Canada

Unnamed facility

Bogotá, Colombia

Outcomes

Primary Outcomes

Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.

Time frame: Baseline, Month 39/Final Visit

Secondary Outcomes

Average Change From Baseline in BCVA in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

Time frame: Baseline, 39 Months

Change From Baseline in BCVA in the Study Eye

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

Time frame: Baseline, Month 39/Final Visit

Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.