Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders

Last updated: October 25, 2018
Sponsor: Marashi Eye Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uveitis

Macular Edema

Treatment

N/A

Clinical Study ID

NCT03606733
SCS
  • Ages 20-99
  • All Genders

Study Summary

Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 20 years and older

  • Patients with macular edema or degeneration from various pathologies

  • Central macular thickness more than 250 microns

  • Patients who are able to come for all follow-up

Exclusion

Exclusion Criteria:

  • Significant renal disease, defined as a history of chronic renal failure requiringdialysis or kidney transplant.

  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke,transient ischemic attack, or treatment for acute congestive heart failure within 4months prior to randomization

  • For women of child-bearing potential: pregnant or lactating or intending to becomepregnant within the next 3 years.

  • Exam evidence of severe external ocular infection, including conjunctivitis,chalazion, or substantial blepharitis

Study Design

Total Participants: 100
Study Start date:
July 01, 2018
Estimated Completion Date:
September 01, 2019

Study Description

A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.

Connect with a study center

  • Focus Eye Center

    Sofia, Balgarska 1303
    Bulgaria

    Site Not Available

  • Subharti Medical College

    Meerut, Uttar Pardesh 250001
    India

    Site Not Available

  • Marashi Eye Clinic

    Aleppo, 2241511
    Syrian Arab Republic

    Active - Recruiting

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