Abstract | PURPOSE: DESIGN: : Prospective, randomized, dose-escalation pilot study comparing single injection of 2 mg versus 4 mg doses of IVTA. METHODS: : Inclusion criteria included clinically significant DME persisting >/=3 months after maximal laser treatment and visual acuity </=20/40. Best-corrected ETDRS vision, intraocular pressure, presence of DME, and fluorescein angiography (FA) were evaluated at 3 months and 6 months after injection. RESULTS: : Mean change in visual acuity at 3 months compared to baseline was 7.1 letters (P = 0.01) in the 2 mg group and 12.5 letters in the 4 mg group (P < 0.0001). However, there was not a significant difference in visual improvement between the 2 mg and 4 mg dose groups (P = 0.11). Vision improved >15 letters at 3 months in 23% (3/13) of 2 mg group and in 33% (5/15) of 4 mg group (P = 0.69), and 0% (0/11) and 21% (3/14) at 6 months, respectively (P = 0.23). Visual improvement was more likely in cystoid-type DME than diffuse DME. Intraocular pressure rise of >/=10 mmHg occurred in 19% (3/16) of 2 mg group and 41% (7/17) of 4 mg group. CONCLUSIONS: : Both doses of IVTA were well tolerated and had significant positive effects on refractory DME for short term. There were consistent trends throughout the study that suggest that a 4 mg IVTA may be more effective than a 2 mg dose. The benefit of IVTA was greater for cystoid-type DME.
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Authors | Judy E Kim, John S Pollack, David G Miller, Robert A Mittra, Richard F Spaide, Isis Study Group |
Journal | Retina (Philadelphia, Pa.)
(Retina)
Vol. 28
Issue 5
Pg. 735-40
(May 2008)
ISSN: 0275-004X [Print] United States |
PMID | 18463518
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Glucocorticoids
- Triamcinolone Acetonide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Diabetic Retinopathy
(drug therapy)
- Female
- Fluorescein Angiography
- Glucocorticoids
(administration & dosage)
- Humans
- Injections
- Intraocular Pressure
(drug effects)
- Macular Edema
(drug therapy)
- Male
- Middle Aged
- Pilot Projects
- Prospective Studies
- Single-Blind Method
- Treatment Outcome
- Triamcinolone Acetonide
(administration & dosage)
- Visual Acuity
(drug effects)
- Vitreous Body
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