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

Not Applicable

• Conditions: Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
• Interventions: Procedure: Custom suorachoroidal needle

• Registration Number: NCT03606733
• Lead Sponsor: Marashi Eye Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-07-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A custom made Suprachoroidal needle for macular diseases	Custom suorachoroidal needle	A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieved visual acuity improvement	12 weeks	To measure best corrected visual acuity using using Snellen chart or equivalent

Secondary Outcome Measures

Name	Time	Method
Amount of Central macular thickness reduction in microns	12 weeks	Using optical coherence tomography in monthly bases to measure central retinal thickness
Proportion of eyes with Increased intraocular pressure	12 weeks	To measure intraocular pressure using Goldmann applanation tonometer

Trial Locations

Locations (1)

Marashi Eye Clinic; 🇸🇾 Aleppo, Syrian Arab Republic