Clinical trial NCT00168389: A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye
timeFrame: Baseline, Month 39/Final Visit
Secondary outcomes:
measure: Average Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, 39 Months
measure: Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, Month 39/Final Visit
measure: Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye
timeFrame: Baseline, Month 39/Final Visit
measure: Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, 39 Months
measure: 10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
timeFrame: Baseline, 39 Months
measure: Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
timeFrame: 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
Other outcomes:
Locations:
city: Inglewood
country: United States
state: California
city: Westmead
country: Australia
state: New South Wales
city: Toronto
country: Canada
state: Ontario
city: Prague
country: Czech Republic
city: Hamburg
country: Germany
city: Tel Aviv
country: Israel
city: Rockwell Center, Makati
country: Philippines
city: Coimbra
country: Portugal
city: Cape Town
country: South Africa
city: Barcelona
country: Spain
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
citation: Yoon YH, Boyer DS, Maturi RK, Bandello F, Belfort R Jr, Augustin AJ, Li XY, Bai Z, Hashad Y; Ozurdex MEAD Study Group. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol. 2019 Dec;257(12):2639-2653. doi: 10.1007/s00417-019-04464-2. Epub 2019 Oct 25.
citation: Danis RP, Sadda S, Li XY, Cui H, Hashad Y, Whitcup SM. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials. Br J Ophthalmol. 2016 Jun;100(6):796-801. doi: 10.1136/bjophthalmol-2015-306823. Epub 2015 Nov 18.
citation: Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. BMC Ophthalmol. 2015 Oct 30;15:150. doi: 10.1186/s12886-015-0148-2.