Original ArticleIntravitreal Triamcinolone for Refractory Diabetic Macular Edema: Two-Year Results of a Double-Masked, Placebo-Controlled, Randomized Clinical Trial
Section snippets
Patient Enrollment
This study was conducted in accordance with the Declaration of Helsinki and was approved by the South Eastern Sydney Area Health Service and University of Sydney research ethics committees. Safety data were reviewed by an independent safety-monitoring committee.⁎ Patients were recruited from the retina clinics of Sydney Eye Hospital, a major public tertiary referral center, from March 2002 to April 2003. Patients with severe (involving the central fovea11) diabetic macular edema, diffuse or
Results
A total of 69 eyes from 41 patients were included in the trial, of which 34 eyes were randomized to receive intravitreal TA and 35 to a placebo. Figure 1 shows the flow of patients through the study. Two-year data were available for 60 of 69 (87%) eyes of 35 of 41 (85%) patients; 9 eyes of 6 patients were lost to follow-up, of which 6 received the placebo and 3 received intravitreal TA. For the 27 patients with both eyes receiving different treatments, the average age was 64 years, and 13 (48%)
Discussion
This study demonstrates for the first time that treatment with intravitreal TA reduces thickening and improves vision for up to 2 years in eyes with advanced diabetic macular edema. Previous short-term uncontrolled studies could not address the possibility of spontaneous improvement that may occur in diseases such as diabetic retinopathy, nor did they take account of the effect of removal of steroid-induced cataract, which might eventually leave eyes worse off because cataract surgery is known
References (22)
- et al.
Macular edemaa complication of diabetic retinopathy
Surv Ophthalmol
(1984) Diabetic retinopathy
Clin Endocrinol Metab
(1977)- et al.
Intravitreal triamcinolone acetonide for diabetic diffuse macular edema. Preliminary results of a prospective controlled trial
Ophthalmology
(2004) - et al.
Intravitreal triamcinolone for refractory diabetic macular edema
Ophthalmology
(2002) - et al.
Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment. Three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial
Ophthalmology
(2004) - et al.
Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales
Ophthalmology
(2003) - et al.
Influence of phacoemulsification and intraocular lens implantation on the course of diabetic retinopathy
J Cataract Refract Surg
(1999) - et al.
Complications of intravitreal injection of triamcinolone acetonide
Can J Ophthalmol
(2005) - et al.
Acute endophthalmitis following intravitreal triamcinolone acetonide injection
Am J Ophthalmol
(2003) Effects of aspirin treatment on diabetic retinopathy
Ophthalmology
(1991)
Progressive enlargement of scattered photocoagulation scars in diabetic retinopathy
Retina
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2021, Advanced Drug Delivery ReviewsCitation Excerpt :The interval between injections has also been reported to be dose-dependent, ranging from 6 to 9 months and 2–4 months for a 20 mg and 4 mg dose, respectively [99]. In a 2-year, randomized, placebo-controlled trial, repeated intravitreal injection of 4 mg TA in patients with refractory DMO resulted in the improvement of visual acuity and reduction of macular thickness [100]. After 5 years, the majority of patients that had initially improved with this therapy, were able to maintain their gains [101].
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Manuscript no. 2005-994.
This study was funded by grants from the Sydney Eye Hospital Foundation, Sydney, Australia; Ophthalmic Research Institute of Australia, Surry Hills, Australia; Juvenile Diabetes Research Foundation, New York, New York; and Diabetes Australia Research Trust, Canberra, Australia. The study was investigator initiated and unsupported by the pharmaceutical industry.
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Dr Gillies is included as an inventor on patents relating to the formulation of triamcinolone for ocular use and its use for the treatment of retinal neovascularization but not macular edema.
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Drs Sutter, Simpson, and Larsson; Ms Ali; and Dr Zhu have no conflicting or proprietary interests.