Branch Retinal Vein Occlusion, Central Serous Retinopathy With Pit of Optic Disc, Commotio Retinae, Epiretinal Membrane, Macular Edema, Radiation Retinopathy, Vitritis
Conditions
Keywords
Macular Edema, Radiation Retinopathy, Branch Retinal Vein Occlusion, Epiretinal Membrane, Central Serous Retinopathy with Pit of Optic Disc, Commotio Retinae, Vitritis
Brief summary
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
Detailed description
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. 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 interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.
Interventions
Sustained Release Episcleral 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
* 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 macular edema, within the central subfield (CSF); * Inflammatory disorders of the sclera, choroid, retina or vitreous
Exclusion criteria
* 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 |
|---|---|---|
| A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. | 12 Months | Assessment of ocular safety as measured by comprehensive ophthalmic exam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A secondary outcome is assessment of visual acuity. | 12 Months | Secondary outcome is assessment of visual acuity. |
| A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT). | 12 Months | A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT). |
Countries
United States
Outcome results
None listed