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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
Age >= 18 years;
No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 60 Other Conditions

Summary

This trial will test if a new drug is safe for patients with a certain eye condition. The drug's effect on inflammation will also be studied.

Who is the study for?
This trial is for adults over 18 with Type I or II diabetes who have a specific level of vision impairment due to diabetic macular edema. They should have tried other treatments like laser or anti-VEGF therapy. People with a history of glaucoma or steroid-induced eye pressure issues can't join.
What is being tested?
The study tests the safety and effectiveness of Episcleral Dexamethasone, which is placed near the eye, in patients with stubborn swelling in the retina caused by diabetes (refractory diabetic macular edema).
What are the potential side effects?
Potential side effects may include increased eye pressure, discomfort at the application site, blurred vision, cataract formation, and possible risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have never had glaucoma or eye pressure issues from steroids.
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I have had laser, anti-VEGF therapy, or eye injections before.
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I have type I or II diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The measure of the study is safety assessment.
Secondary study objectives
are assessment of visual acuity.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 1Experimental Treatment1 Intervention
Phase I open label study

Find a Location

Who is running the clinical trial?

Targeted Therapy Technologies, LLCLead Sponsor
4 Previous Clinical Trials
77 Total Patients Enrolled
Theodore Leng, MDPrincipal InvestigatorStanford Medicine
2 Previous Clinical Trials
5 Total Patients Enrolled
~0 spots leftby Nov 2025
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