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

Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
• Intervention / Treatment: Procedure: Custom suorachoroidal needle

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ameen Marashi; Phone Number: 963937785557; Email: ameenmarashi@hotmail.com

Study Locations

• Syrian Arab Republic
  • Aleppo, Syrian Arab Republic, 2241511
    • Recruiting
    • Marashi Eye Clinic
    • Contact: Ameen Marashi, MD; Phone Number: 963212241511; Email: ameenmarashi@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A custom made Suprachoroidal needle for macular diseases; A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana	Procedure: Custom suorachoroidal needle; Custom made Supra Choroidal Space needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieved visual acuity improvement	To measure best corrected visual acuity using using Snellen chart or equivalent	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marashi Eye Clinic

Publications and helpful links

General Publications

• Marashi A. Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle. Adv Ophthalmol Vis Syst. 2018;8(5):277-281. DOI: 10.15406/aovs.2018.08.00321

Helpful Links

• Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: July 22, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Panuveitis; Uveal Diseases; Macular Degeneration; Macular Edema; Uveitis; Uveitis, Posterior
• Other Study ID Numbers: SCS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No