NCT04005430Active, not recruitingPhase 1
A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes
Targeted Therapy Technologies, LLC1 site in 1 country1 target enrollmentStarted: April 3, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- The primary outcome measure of the study is safety assessment.
Study Overview
Brief Summary
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.
Detailed Description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision in patients with diabetic macular edema.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type I or II diabetes;
- •Age >= 18 years;
- •Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
- •Ophthalmoscopic evidence of center-involved DME, within the central subfield (CSF);
- •OCT CSF thickness value (microns):
- •Zeiss Cirrus: ≥290 in women; ≥305 in men
- •Heidelberg Spectralis: ≥305 in women; ≥320 in men
- •Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids;
- •No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.
Exclusion Criteria
- •History of chronic renal failure requiring dialysis or kidney transplant;
- •Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
- •Evidence of external ocular infection;
- •History of open-angle glaucoma or intraocular pressure >= 25 mmHg;
- •History of steroid-induced IOP elevation that required IOP-lowering treatment;
- •History of prior herpetic ocular infection;
- •History of intravitreal or periocular corticosteroids within 3 months prior to enrollment;
- •History of macular laser photocoagulation within 4 months prior to enrollment;
- •History of antiangiogenic therapy within 4 weeks prior to enrollment;
- •History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment;
- •Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments;
- •No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study;
- •Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment;
- •Degenerative myopia;
- •Malignant intraocular disease;
- •Inability to understand informed consent, cooperate with testing or return to follow up visits; Pregnant or lactating women; Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
Arms & Interventions
Phase 1
Experimental
Phase I open label study
Intervention: Episcleral Dexamethasone (Drug)
Outcomes
Primary Outcomes
The primary outcome measure of the study is safety assessment.
Time Frame: 12 Months
The main outcome of the study is safety assessment.
Secondary Outcomes
- Secondary outcome are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).(12 Months)
- Secondary outcomes are assessment of visual acuity.(12 Months)
Investigators
Study Sites (1)
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