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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168389
• Other study ID #: 206207-010
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 10, 2014
• Start date: February 2005
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone
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.

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Germany,  Israel,  Philippines,  Portugal,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 39/Final Visit	No
Secondary	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.	Baseline, 39 Months	No
Secondary	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.	Baseline, Month 39/Final Visit	No
Secondary	Percentage of Patients With a BCVA Improvement of =10 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.	Baseline, Month 39/Final Visit	No
Secondary	Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)	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.	Baseline, 39 Months	No
Secondary	10th Percentile for Time to 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). 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.	Baseline, 39 Months	No
Secondary	Percentage of Patients With BCVA Improvement of =15 Letters From Baseline in the Study Eye at 3-month Intervals	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.	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	No