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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606733
• Other study ID #: SCS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2018
• Source: Marashi Eye Clinic
• Contact: Ameen Marashi
• Phone: 963937785557
• Email: ameenmarashi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Custom suorachoroidal needle
Custom made Supra Choroidal Space needle

Locations

Country	Name	City	State
Syrian Arab Republic	Marashi Eye Clinic	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
Marashi Eye Clinic

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieved visual acuity improvement	To measure best corrected visual acuity using using Snellen chart or equivalent	12 weeks
Secondary	Amount of Central macular thickness reduction in microns	Using optical coherence tomography in monthly bases to measure central retinal thickness	12 weeks
Secondary	Proportion of eyes with Increased intraocular pressure	To measure intraocular pressure using Goldmann applanation tonometer	12 weeks

External Links

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