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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

Study 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.Check my eligibility

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.See study design

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 below

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I have inflammation in parts of my eye.

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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

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

A measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.

Secondary outcome measures

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

A is assessment of visual acuity.

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

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Targeted Therapy Technologies, LLCLead Sponsor

3 Previous Clinical Trials

46 Total Patients Enrolled

2 Trials studying Macular Edema

4 Patients Enrolled for Macular Edema

Theodore Leng, MDPrincipal InvestigatorStanford Medicine

2 Previous Clinical Trials

4 Total Patients Enrolled

2 Trials studying Macular Edema

4 Patients Enrolled for Macular Edema

Frequently Asked Questions

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

Are there any open opportunities to participate in this trial at the present time?

"The information on clinicaltrials.gov states that this particular trial is no longer actively seeking participants, as the last edit was made on October 7th 2019. However, there are still 229 other trials recruiting patients at this moment in time."

Answered by AI

Has the open label Phase I study been sanctioned by the FDA?

"The risk of potential harm associated with the Phase I open label study is assessed to be a 1 given that there is restricted data confirming its safety and efficacy."

Answered by AI