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

Phase 1

Active, not recruiting

• Conditions: Refractory Diabetic Macular Edema
• Interventions: Drug: Episcleral Dexamethasone

• Registration Number: NCT04005430
• Lead Sponsor: Targeted Therapy Technologies, LLC

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.

Study Timeline

• Study Start: 2019-04-03
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1	Episcleral Dexamethasone	Phase I open label study

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of the study is safety assessment.	12 Months	The main outcome of the study is safety assessment.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).	12 Months
Secondary outcomes are assessment of visual acuity.	12 Months	Secondary outcomes are assessment of visual acuity.

Trial Locations

Locations (1)

Stanford Medicine Ophthalmology; 🇺🇸 Palo Alto, California, United States