Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 22, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 29, 2018
October 1, 2018
1.1 years
July 22, 2018
October 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients achieved visual acuity improvement
To measure best corrected visual acuity using using Snellen chart or equivalent
12 weeks
Secondary Outcomes (2)
Amount of Central macular thickness reduction in microns
12 weeks
Proportion of eyes with Increased intraocular pressure
12 weeks
Study Arms (1)
A custom made Suprachoroidal needle for macular diseases
EXPERIMENTALA custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana
Interventions
Custom made Supra Choroidal Space needle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marashi Eye Clinic
Aleppo, 2241511, Syria
Related 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
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
July 22, 2018
First Posted
July 31, 2018
Study Start
July 1, 2018
Primary Completion
August 1, 2019
Study Completion
September 1, 2019
Last Updated
October 29, 2018
Record last verified: 2018-10