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

M

Marashi Eye Clinic

Status

Unknown

Conditions

Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis

Treatments

Procedure: Custom suorachoroidal needle

Study type

Interventional

Funder types

Other

Identifiers

NCT03606733
SCS

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 99 years old

Volunteers

No Healthy Volunteers

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 criteria

  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Trial design

100 participants in 1 patient group

A custom made Suprachoroidal needle for macular diseases
Experimental group
Description:
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana
Treatment:
Procedure: Custom suorachoroidal needle

Trial contacts and locations

0

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Central trial contact

Ameen Marashi

Data sourced from clinicaltrials.gov

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