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

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Dexamethasone; Other: Sham

• Registration Number: NCT00168389
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Disposition First Submitted: 2013-06-21
• Disposition First Submitted QC: 2013-06-21
• Disposition First Posted: 2013-07-01
• Status Verified: 2014-07
• Results First Submitted: 2014-07-10
• Results First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Results First Posted: 2014-08-04
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

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 first 12 months of study;
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone 700 μg	Dexamethasone	700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Sham	Sham	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.
Dexamethasone 350 μg	Dexamethasone	350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye	Baseline, Month 39/Final Visit	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BCVA in the Study Eye	Baseline, Month 39/Final Visit	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.
Average Change From Baseline in BCVA in the Study Eye	Baseline, 39 Months	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.
Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye	Baseline, Month 39/Final Visit	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.
Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)	Baseline, 39 Months	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. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye	Baseline, 39 Months	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). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals	Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit	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.