Macular Edema Clinical Trial
Official title:
Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous
Verified date | November 2023 |
Source | Targeted Therapy Technologies, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 2 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Medicine Ophthalmology | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Targeted Therapy Technologies, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 Months | |
Secondary | A secondary outcome is assessment of visual acuity. | Secondary outcome is assessment of visual acuity. | 12 Months | |
Secondary | 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). | 12 Months |
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