Clinical trial NCT04005430: A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema
Official title: A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Refractory Diabetic Macular Edema
Lead sponsor: Targeted Therapy Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary outcome measure of the study is safety assessment.
timeFrame: 12 Months
Secondary outcomes:
measure: Secondary outcomes are assessment of visual acuity.
timeFrame: 12 Months
measure: Secondary outcome are assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).
timeFrame: 12 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medicine Ophthalmology
state: California
Study officials:
affiliation: Stanford Medicine
name: Theodore Leng, MD
role: PRINCIPAL_INVESTIGATOR
References: