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Study Detail: Posurdex DME Laser

Trial Description Summary : To assess Safety and Efficacy of 700ug Dexamethasone delivered to the eye in a new way. This new system is the Posterior Segment Drug Delivery System (DEXDDS) applicator. The study also does Laser treatments and compares either the laser treatment alone OR the study drug and laser treatment on the effect of diabetic macular edema.

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

NA

macular edema

Pending

> 18 yrs

Allergan

206027-012

Study Duration: Maximum 9 visits over 66 weeks

Eligibility Criteria:

Inclusion Criteria

· Over 18 M or F with Type 1 or 2 DM with regular use of insulin or oral hypoglycemic agent.

· Random plasma glucose ≥ 200 (regardless of last meal)

· 8 hr fasting glucose of ≥ 126 or 2 hr. post load glucose of ≥ 200.

· BCVA Study Eye 20/50 -20/200 Non Study Eye 20/100 or better!

· OCT of ≥275 microns in central 1mm macular subfield on Retinal map.

· Screening labs w/i lab reference range out of range labs must be acceptable to investigator.

Exclusion Criteria

Opththalmic exclusion

· Hx. Of extensive laser tx. To SE, scars close to FAZ, Macular Ischemia.

· Other Ocular Dz. (ARMD, POAG, Media Opacity, SRF, Foveal pigment changes or atrophy.

· Visible Scleral Thinning, BRVO, CRVO, Uveitis, Irvine Gass Syndrome, any other condition contributing to ME.

· Pseudophakia "OK" if ≥ 6 mo prior to Day 0. NO ACIOL or Aphakia.

· Epi Retinal Membrane or Vitreomacular traction.

· "Active" optic disc or retinal neovascularization.

· Rubeosis iridis at day 0.

· Hx of PPV or herpetic infection in SE or Adnexa

· Intra Ocular Surgery or any type of laser within 13 weeks of study entry.

· Anticipated need for ocular surgery during study.

· IOP ≥ 23 (No Meds), ≥ 21(on 1 med or if using 2 or more combination drugs count as 2), stable med. Use for 6 weeks prior to entry.

· IV Steroid use except if it was ≤ 4mg triamcinolone acetonide given ≥ 26 weeks prior to study.

· Peri Ocular Steroid ≤ 26 weeks prior to entry either eye.

· Increase in IOP with corticosteroid use ≥10 and absolute IOP ≥25, required surgery, laser or more then 1 med to lower IOP. Either Eye

· Central Serous Retinopathy Either Eye

· Toxoplasmosis (active or inactive) active ocular infection or contraindication for pupil dilation OU.

General medical exclusion

· HbA1c ≥ 11% at Day 0

· Initiation of Medical Therapy for DM or Changes from oral to insulin within 4 months of study entry.

· Hx. of corticosteroid use within 12 weeks prior to entry (Inhaled, Intranasal, Intra articular/bursal OK). Anticipated use of oral, IV,IM, Epidural, Rectal or extensive dermal use during study.

· Uncontrolled Systemic Disease, Renal Failure or Hemodyialysis w/i 6mo or anticipated during study.

· Use of Warfin, Heparin, Enoxaprin or similar agents within 2 weeks of study entry or anticipated use during study.

Study Title : Allergan AGN 206207-012 "A 52 –Week, Masked, Multicenter, Randomized, Controlled Trail (With Up to 13 Weeks additional Follow up) to assess the Safety and Efficacy of 700ug Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in Combination with Laser Photocoagulation Compared with Laser Photocoagulation Alone in the Treatment of Subject With Diffuse Diabetic Macular Edema (DME)"

Trial Contact Information

Site

Study Coordinator

Youngstown

Josel 216/831-5704 ext. 6800