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

NCT ID: NCT04005430

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2024-09-30

Brief Summary

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.

Detailed Description

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision in patients with diabetic macular edema.

Conditions

Refractory Diabetic Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1

Phase I open label study

Group Type: EXPERIMENTAL

Episcleral Dexamethasone

Intervention Type: DRUG

Sequestered Transscleral, Controlled-Release Dexamethasone

Interventions

Episcleral Dexamethasone

Sequestered Transscleral, Controlled-Release Dexamethasone

Intervention Type: DRUG

Other Intervention Names

Sustained Release Transscleral Dexamethasone

Eligibility Criteria

Inclusion Criteria

• Type I or II diabetes;
• 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 DME, within the central subfield (CSF);
• OCT CSF thickness value (microns):

• Zeiss Cirrus: ≥290 in women; ≥305 in men
• Heidelberg Spectralis: ≥305 in women; ≥320 in men
• Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids;
• No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.

Exclusion Criteria

• History of chronic renal failure requiring dialysis or kidney transplant;
• Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
• Evidence of external ocular infection;
• History of open-angle glaucoma or intraocular pressure >= 25 mmHg;
• History of steroid-induced IOP elevation that required IOP-lowering treatment;
• History of prior herpetic ocular infection;
• History of intravitreal or periocular corticosteroids within 3 months prior to enrollment;
• History of macular laser photocoagulation within 4 months prior to enrollment;
• History of antiangiogenic therapy within 4 weeks prior to enrollment;
• History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment;
• Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments;
• No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study;
• Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment;
• Degenerative myopia;
• Malignant intraocular disease;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Targeted Therapy Technologies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Leng, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Medicine

Locations

Stanford Medicine Ophthalmology

Palo Alto, California, United States

Countries

United States

Other Identifiers

3TDEX01

Identifier Type: -

Identifier Source: org_study_id