Back to resultsSuprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
Primary Purpose
Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
Status
Unknown status
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Custom suorachoroidal needle
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
Eligibility Criteria
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
Sites / Locations
- Marashi Eye ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A custom made Suprachoroidal needle for macular diseases
Arm Description
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana
Outcomes
Primary Outcome Measures
Proportion of patients achieved visual acuity improvement
To measure best corrected visual acuity using using Snellen chart or equivalent
Secondary Outcome Measures
Amount of Central macular thickness reduction in microns
Using optical coherence tomography in monthly bases to measure central retinal thickness
Proportion of eyes with Increased intraocular pressure
To measure intraocular pressure using Goldmann applanation tonometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03606733
Brief Title
Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
Official Title
Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marashi Eye Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A custom made Suprachoroidal needle for macular diseases
Arm Type
Experimental
Arm Description
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana
Intervention Type
Procedure
Intervention Name(s)
Custom suorachoroidal needle
Intervention Description
Custom made Supra Choroidal Space needle
Primary Outcome Measure Information:
Title
Proportion of patients achieved visual acuity improvement
Description
To measure best corrected visual acuity using using Snellen chart or equivalent
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Amount of Central macular thickness reduction in microns
Description
Using optical coherence tomography in monthly bases to measure central retinal thickness
Time Frame
12 weeks
Title
Proportion of eyes with Increased intraocular pressure
Description
To measure intraocular pressure using Goldmann applanation tonometer
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ameen Marashi
Phone
963937785557
Email
ameenmarashi@hotmail.com
Facility Information:
Facility Name
Marashi Eye Clinic
City
Aleppo
ZIP/Postal Code
2241511
Country
Syrian Arab Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameen Marashi, MD
Phone
963212241511
Email
ameenmarashi@hotmail.com
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
Links:
URL
http://medcraveonline.com/AOVS/AOVS-08-00321.pdf
Description
Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle
Learn more about this trial
Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
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