Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

Allergan262 enrolled

Overview

This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

262

Conditions

Macular Edema

Interventions

700 μg DexamethasoneDRUG

700 μg Dexamethasone intravitreal injection in the study eye on Day 1.

ShamOTHER

Sham administered in the study eye on Day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: -Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Exclusion Criteria: * History of glaucoma, ocular hypertension or optic nerve head change * Any active bacterial, viral, parasitic, or fungal infections in either eye * Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start * History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start * Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start * Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start * Use of topical ophthalmic corticosticosteroids within 2 weeks of study start

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (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). 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 means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.

Time frame: Baseline, 6 Months

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, 6 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). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.

Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Percentage of Patients With 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.

Data from ClinicalTrials.gov

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