Status:
NOT_YET_RECRUITING
Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema, CRVO, Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema Following Pars Plana Vitrectomy
Lead Sponsor:
Tanta University
Conditions:
Retinal Edema
Eligibility:
All Genders
Phase:
EARLY_PHASE1
Brief Summary
Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA).
Detailed Description
* Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus and 60 eyes with central retinal vein occ...
Eligibility Criteria
Inclusion
- Patients fulfilling one or more of the following criteria will be considered to have resistant DME after at least 3 consecutive monthly anti VEGF injections in the previous 6 months:
- Central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT).
- Reduction of retinal thickness by less than 10% of baseline retinal thickness.
- Suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart) and patients with recent onset central retinal vein occlusion less than 3 months.
Exclusion
- Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- Previous laser photocoagulation.
- Intravitreal injection of triamcinolone acetonide.
- Prior ocular inflammation.
- The presence of retinal degeneration.
- Patients who didnot complete 6 months of follow up
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04690608
Start Date
December 1 2024
End Date
February 1 2025
Last Update
March 5 2024
Active Locations (1)
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1
Tanta University
Tanta, El Gharbia, Egypt, 31111