Macular Edema
Conditions
Brief summary
This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.
Interventions
DRUGtriamcinolone acetonide
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2) * Patient has in the study eye, 20/40 - 20/160 vision * Patient has Type 1 or Type 2 diabetes * Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control
Exclusion criteria
* Patient has had any active ocular infection in either eye * Patient has intraocular pressure \> 22 mmHg or a diagnosis of glaucoma * Patient has cystoid macular edema in the study eye * Patient has a history of elevated IOP in response to ocular steroid therapy in either eye * Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1 * Patient has an HbAIc value \> 10% at Visit 1 * Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months * Patient has a history of cancer within 5 years prior to signing informed consent * Patient has clinically-relevant chronic renal failure * Patient has high blood pressure * Patient has coronary heart disease * Patient has known allergies to steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. | After 12 months of therapy. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy | After 12 months of therapy. |
Outcome results
None listed