The Use of Intravitreal Injection of Triamcinolone Acetonide in Diabetic Patients to Reduce Diabetic Macular Edema

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000249752

Acronym

None

Enrollment

Registered

2013-03-04

Start date

2010-03-30

Completion date

2011-03-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aim: To evaluate the changes of intraocular pressure after intravitreal injection of triamcinolone acetonide for the management of diabetic macular edema . Design: This prospective interventional two-arm dose-response study. Materials and Methods: Nineteen patients with bilateral diabetic macular edema were included, one eye for every patient underwent intravitreal injection of 4m triamcinolone acetonide (group A, 19 eyes) and the other eye of the same patient underwent intravitreal injection of 8mg triamcinolone acetonide (group B, 19 eyes), the selection of which eye to receive either dose was random. The patients were followed up for six months after injection , complete Ophthalmological examination and optical coherent topography were done. Results: Intravitreal triamcinolone acetonide was effective in reduction of diabetic macular edema in group A in the first three months only, while in group B with high dose (8mg) the improvement continued for 6 months after injection. Significant intraocular pressure rise was observed in both groups with an incidence of 68.1 % and 73.7% in group A and B respectively. Intraocular pressure lowering drugs were used to control intraocular pressure, two eyes, however, in each group of the same patients needed glaucoma filtration surgery after intractable glaucoma with failure of medical treatment. Conclusions: Although intravitreal injection of triamcinolone acetonide is very effective in managing diabetic macular edema and has a lower cost than other modalities, the rise of intraocular pressure and glaucoma burden is another major concern .High corticosteroid responder is an individualized reaction irrespective of the intravitreal triamcinolone acetonide dose used.

Interventions

Nineteen patients with bilateral diabetic macular edema were included, one eye for every patient underwent intravitreal injection of 4mg triamcinolone acetonide (group A, 19 eyes) and the other eye of the same patient underwent intravitreal injection of 8mg triamcinolone acetonide (group B, 19 eyes), the selection of which eye to receive either dose was random. The patients were followed up for six months after injection , complete Ophthalmological examination and optical coherent topography we

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

The major eligibility criteria for the study eyes included the following: (1) best-corrected visual acuity letter score between 20/40 and 20/320; (2) definite retinal thickening resulting from DME on clinical examination involving the center of the macula assessed to be the main cause of visual loss; (3) retinal thickness measured with optical coherence tomography (OCT) of 250 micro m or more in the central subfield ;(4) Grid laser treatment was done at least three months earlier.

Exclusion criteria

Principal exclusion criteria included; (1) prior treatment with intravitreal corticosteroids (at any time), peribulbar steroid injection within the prior 6 months, or pars plana vitrectomy (at any time); (2) a history of glaucoma or steroid-induced IOP elevation that required IOP-lowering treatment; (3) average intraocular pressure of 23 mm Hg or more after three preinjection evaluations; (4) eyes with ischemic maculopathy and (5) patients with foveal traction detected with OCT.

Outcome results