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.
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 best corrected visual acuity (BCVA) (ETDRS letters) and OCT central macular thickness.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
Apec Hospital La Ceguera
Mexico City, Mexico
Observation of dose limiting toxicity
The primary endpoint of this study is observation of dose limiting toxicity and the maximum tolerated dose. This determination will be made by the following criteria : Ocular Adverse Events by standard Clinical Ophthalmic examination Visual acuity changes from BCVA (ETDRS equivalent) at baseline by Slit Lamp Bio-microscopy, Tonometry, Indirect Ophthalmoscopy/ Fundus Photography, Fluorescein Angiography, OCT Central Macular Thickness, and ERG Examination
Time frame: 6 months
Improvements in BCVA ETDRS
Reduction in OCT central macular thickness in subjects with baseline diabetic macular edema and Improvements in BCVA ETDRS letters at 4 meters from baseline to 30 days, 60 days and 90 days post injection evaluations with safety evaluations to 180 days
Time frame: 6 months
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7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops