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

Targeted Therapy Technologies

Status and phase

Active, not recruiting

Phase 1

Conditions

Refractory Diabetic Macular Edema

Treatments

Drug: Episcleral Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT04005430

3TDEX01

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.