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

• Status: Unknown status
• Trial end date: 2020-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targeted Therapy Technologies, LLC
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

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.