Status:
COMPLETED
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
Lead Sponsor:
Unity Health Toronto
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in...
Eligibility Criteria
Inclusion
- Presence of Non Proliferative Diabetic Retinopathy (NDPR) or Proliferative Diabetic Retinopathy as confirmed by IntraVenous Fluorescein Angiography (IVFA)
- Prior treatment with ≥ 6 intravitreal anti-VEGF injections but no treatment in last 4 weeks
- Less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline
- Less than 10% reduction in macular volume
- Age 18 years or older
- Subjects with Type I or II diabetes mellitus
- snellen Acuity 20/40 to 20/400 and its ETDRS equivalent
- Ability to provide signed informed consent
- Capable of complying with study protocol.
Exclusion
- Previous intraocular injection of steroid medication.
- Concurrent ocular disease (wet Age-Related Macular Degeneration, significant Epiretinal Membrane, vitreomacular traction etc) that would limit visual acuity in the opinion of the treating physician
- Proliferative diabetic retinopathy in the study eye or PanRetinal Photocoagulation within the last 12 months
- Poor glycemic control HbA1c \>9%
- Prior vitrectomy surgery.
- Prior intraocular surgery within 3 months in study eye
- Laser treatment within 3 months of study eye
- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to study enrollment.
- Known history of Intraocular Pressure (IOP) elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
- Known allergies to study drug or fluorescein
- History of stroke or acute Myocardial Infarction within 6 months of enrolment
- Patients receiving dialysis for renal failure
- Patients currently on systemic immunosuppression
- Patients with glaucoma
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02221453
Start Date
September 1 2015
End Date
December 1 2016
Last Update
September 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Michael's Hospital Eye Clinic
Toronto, Ontario, Canada, M5C2T2