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

NCT04005430 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 3TDEX01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure of the study is safety assessment.

  The main outcome of the study is safety assessment.

  12 Months

Secondary Outcomes (2)

• Secondary outcomes are assessment of visual acuity.

  12 Months

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

  12 Months

Study Arms (1)

Phase 1

EXPERIMENTAL

Phase I open label study

Drug: Episcleral Dexamethasone

Interventions

Episcleral Dexamethasone DRUG

Sequestered Transscleral, Controlled-Release Dexamethasone

Also known as: Sustained Release Transscleral Dexamethasone

Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Targeted Therapy Technologies, LLC: lead

Study Sites (1)

Stanford Medicine Ophthalmology

Palo Alto, California, 94303, United States

Location

Study Officials

• Theodore Leng, MD

  Stanford Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 2, 2019
• Study Start: April 3, 2019
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)