A Phase 1 interventional study of Episcleral Dexamethasone in Macular Edema, Radiation Retinopathy and Branch Retinal Vein Occlusion, sponsored by Targeted Therapy Technologies, LLC. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Targeted Therapy Technologies, LLC · Phase 1, Interventional, and Treatment
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.
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Targeted Therapy Technologies, LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone Other Names: • Sustained Release Transscleral Dexamethasone
Drug: Episcleral Dexamethasone
Sustained Release Episcleral Dexamethasone
Also known as: Sequestered Transscleral, Controlled-Release Dexamethasone, Sustained Release Transscleral Dexamethasone
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Assessment of ocular safety as measured by comprehensive ophthalmic exam.
Time frame: 12 Months
A secondary outcome is assessment of visual acuity.
Secondary outcome is assessment of visual acuity.
Time frame: 12 Months
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
Time frame: 12 Months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Targeted Therapy Technologies, LLC