← Back to Search

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

Study 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.Check my eligibility

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).See study design

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

Select...

I am 18 years old or older.

Select...

I have never had glaucoma or eye pressure issues from steroids.

Select...

I have had laser, anti-VEGF therapy, or eye injections before.

Select...

I have type I or II diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The measure of the study is safety assessment.

Secondary outcome measures

are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).

are assessment of visual acuity.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1Experimental Treatment1 Intervention

Phase I open label study

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Targeted Therapy Technologies, LLCLead Sponsor

3 Previous Clinical Trials

47 Total Patients Enrolled

Theodore Leng, MDPrincipal InvestigatorStanford Medicine

2 Previous Clinical Trials

5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for participants in this trial?

"According to the clinicaltrials.gov webpage, this particular trial is not presently recruiting any participants. It was initially posted on April 3rd 2019 and most recently updated June 28th 2019; however, there are 124 other active clinical trials that currently require patient enrolment."

Answered by AI

What potential risks might participants face during Phase 1 of this experiment?

"From 1 to 3, Power's estimation of the safety for Phase 1 is a rating of one. This indicates that there are scarce clinical data affirming its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

2019. "A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04005430.

All > Macular Edema