Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK0140-001 | |||
| 2008_521 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 100 mcg triamcinolone acetonide |
|
| 2 | Experimental | 500 mcg triamcinolone acetonide |
|
| 3 | Experimental | 925 mcg triamcinolone acetonide |
|
| 4 | No Intervention | sham control - not implanted, no medication |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triamcinolone acetonide | Drug | 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. | After 12 months of therapy. |
| Measure | Description | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |