Refractory Diabetic Macular Edema
Conditions
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.
Interventions
Sequestered Transscleral, Controlled-Release Dexamethasone
Sponsors
Targeted Therapy Technologies, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure of the study is safety assessment. | 12 Months | The main outcome of the study is safety assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcomes are assessment of visual acuity. | 12 Months | Secondary outcomes are assessment of visual acuity. |
| Secondary outcome are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT). | 12 Months | — |
Countries
United States
Outcome results
None listed