Diabetic Retinopathy Clinical Trial
Official title:
Phase I Study of Intravitreal Injections Versus Anterior Sub-Tenon Injections of Triamcinolone Acetonide Formulation for Macular Edema in Retinal Disorders
The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be
a promising treatment for a variety of ocular diseases associated with inflammation. To date,
the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not
been formulated for intraocular use.
The purpose of this study is to evaluate the long-term safety and potential efficacy of novel
intravitreal injections of a preservative-free formulation of triamcinolone acetonide
(TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of
TAC-PF at 20 mg.
The study will be a masked, randomized Phase I study that will enroll 120 participants with
one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema
(DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any
other retinal disease with associated macular edema. At least 21 participants will be
enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36
participants may have one of these diseases or may be enrolled with another retinal disease.
Within each disease strata, at least seven participants will be randomized to each dosing
group. The participants will be randomly assigned to one of the three treatment groups.
The primary outcome will be an assessment of post-injection intraocular toxicity-related
events during the 3-year follow-up, including cataract formation, development of glaucoma,
and any adverse event preventing retreatment. The secondary outcomes will be an improvement
in best-corrected visual acuity (BCVA, EVA) and decreases in retinal thickening and area of
leakage, from baseline to year 1.
The use of intravitreal injections of corticosteroid (triamcinolone acetonide) appears to be
a promising treatment for a variety of ocular diseases associated with inflammation. To date,
the only drug available, "Kenalog-40 Injection" produced by Bristol Myers Squibb, has not
been formulated for intraocular use.
The purpose of this study is to evaluate the long-term safety and potential efficacy of novel
intravitreal injections of a preservative-free formulation of triamcinolone acetonide
(TAC-PF) at two dosage levels (4 mg and 8 mg) compared to anterior sub-tenon injections of
TAC-PF at 20 mg.
The study will be a masked, randomized Phase I study that will enroll 120 participants with
one of the following diseases: age-related macular degeneration (AMD), diabetic macular edema
(DME), central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), or any
other retinal disease with associated macular edema. At least 21 participants will be
enrolled in the four designated disease strata: AMD, DME, CRVO, and BRVO. The remaining 36
participants may have one of these diseases or may be enrolled with another retinal disease.
Within each disease strata, at least seven participants will be randomized to each dosing
group. The participants will be randomly assigned to one of the three treatment groups.
Depending on a participant's response, injections may be repeated at 3-month intervals.
Participants will be followed until the last enrolled participant completes 3 years of
follow-up.
The primary outcome will be an assessment of post-injection intraocular toxicity-related
events during the 3-year follow-up, including cataract formation, development of glaucoma,
and any adverse event preventing retreatment. The secondary outcomes will be an improvement
in best-corrected visual acuity (BCVA) and decreases in retinal thickening and area of
leakage, from baseline to year 1.
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