drugset / Trial / NCT01482871
Safety Study of ALG- 1001 to Treat Diabetic Macular Edema
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters) and OCT central macular thickness.
Timeline
- Start
- 2011-01
- Primary completion
- 2011-11
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risuteganib | Protein / enzyme biologic | 1.5 mg | Intravitreal |
| Subject | Risuteganib | Protein / enzyme biologic | 2.5 mg | Intravitreal |
| Subject | Risuteganib | Protein / enzyme biologic | 5 mg | Intravitreal |
| Subject | Risuteganib | Protein / enzyme biologic | 7.5 mg | Intravitreal |