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Status unknownNCT03606733Updated Oct 29, 2018

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

An interventional study of Custom suorachoroidal needle in Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis, sponsored by Marashi Eye Clinic. Status unknown at 1 site in Syrian Arab Republic. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-10-29.

Sponsored by Marashi Eye Clinic · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
20 Years to 99 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
03

Who can participate

Ages eligible
20 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureCustom suorachoroidal needle

    Custom made Supra Choroidal Space needle

05

What researchers measure

Primary outcomes

  1. Proportion of patients achieved visual acuity improvement

    To measure best corrected visual acuity using using Snellen chart or equivalent

    Time frame: 12 weeks

Secondary outcomes

  1. Amount of Central macular thickness reduction in microns

    Using optical coherence tomography in monthly bases to measure central retinal thickness

    Time frame: 12 weeks

  2. Proportion of eyes with Increased intraocular pressure

    To measure intraocular pressure using Goldmann applanation tonometer

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
  • Marashi Eye Clinic
    Aleppo, 2241511, Syrian Arab Republic
    Recruiting
07

References and documents

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
08

Registry details

Key details

Study ID
NCT03606733
Lead sponsor
Marashi Eye Clinic
Responsible party
Ameen Marashi (Principle investigator, Marashi Eye Clinic) — Principal investigator
First posted
Jul 31, 2018
Start date
Jul 1, 2018
Primary completion
Aug 1, 2019 (estimated)
Completion
Sep 1, 2019 (estimated)
Last update
Oct 29, 2018

Study contacts

Ameen Marashi
Contact
ameenmarashi@hotmail.com
963937785557

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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