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Corticosteroid
Episcleral Dexamethasone for Macular Edema
Phase 1
Waitlist Available
Led By Theodore Leng, MD
Research Sponsored by Targeted Therapy Technologies, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inflammatory disorders of the sclera, choroid, retina or vitreous
Age >= 18 years;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Summary
This trial will test a new eye medication for safety and its ability to reduce inflammation in people with diseases affecting the retina, choroid, and vitreous.
Who is the study for?
This trial is for adults over 18 with certain eye conditions like macular edema, retinal diseases, and inflammation of the retina or vitreous. Participants must have a specific range of visual acuity (roughly between 20/32 to 20/320 vision) and show signs of swelling in the central part of their retina.
What is being tested?
The trial is testing Episcleral Dexamethasone's safety and its ability to reduce inflammation in patients with macular edema or other inflammatory disorders affecting the back part of the eye.
What are the potential side effects?
Potential side effects may include increased pressure inside the eye, cataract formation, infection risk at the site where medicine is applied, and possible allergic reactions to dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have inflammation in parts of my eye.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
Secondary study objectives
A is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
A is assessment of visual acuity.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase I open label studyExperimental Treatment1 Intervention
Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone
Other Names:
• Sustained Release Transscleral Dexamethasone
Find a Location
Who is running the clinical trial?
Targeted Therapy Technologies, LLCLead Sponsor
4 Previous Clinical Trials
76 Total Patients Enrolled
Theodore Leng, MDPrincipal InvestigatorStanford Medicine
2 Previous Clinical Trials
4 Total Patients Enrolled