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Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.

A

Al-Azhar University

Status

Completed

Conditions

Diabetic Macular Edema of Left Eye

Treatments

Drug: Triamcinolone Acetonide
Drug: Formulated Triamcinolone

Study type

Interventional

Funder types

Other

Identifiers

NCT05464953
PSTA and DME

Details and patient eligibility

About

Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.

Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.

Enrollment

75 patients

Sex

All

Ages

40 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diminution of vision due to diabetic macular edema.
  • CMT ≥ 250 µ.
  • Willing to participate in the study.

Exclusion criteria

  • Unwilling to participate in the study, 2)
  • Ischemic RVO,
  • previous laser treatment
  • Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
  • patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion,
  • Cardiac co-morbidities result in significant hemodynamic changes, 7)Respiratory diseases need treatment with antibiotics,
  • Suffering from other chronic diseases as diabetes,
  • Patient with allergy from triamcinolone acetonide.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

Formulated Posterior Sub Tenon Triamcinolone
Active Comparator group
Treatment:
Drug: Formulated Triamcinolone
Posterior Sub Tenon Triamcinolone alone
Active Comparator group
Treatment:
Drug: Triamcinolone Acetonide
suprachoroidal Triamcinolone
Active Comparator group
Treatment:
Drug: Triamcinolone Acetonide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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