Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole

Macular Edema Clinical Trial

Official title:

Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04120311
• Other study ID #: 3TDEX-02
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Targeted Therapy Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.

Description:

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. 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 interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT) and fluorescein angiogram.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 macular edema, within the central subfield (CSF);
• Inflammatory disorders of the sclera, choroid, retina or vitreous

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Central Serous Chorioretinopathy
• Central Serous Retinopathy With Pit of Optic Disc
• Commotio Retinae
• Edema
• Epiretinal Membrane
• Macular Edema
• Radiation Retinopathy
• Retinal Diseases
• Retinal Vein Occlusion
• Vitritis

Intervention

Drug:
• Episcleral Dexamethasone
Sustained Release Episcleral Dexamethasone

Locations

Country	Name	City	State
United States	Stanford Medicine Ophthalmology	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Therapy Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.	Assessment of ocular safety as measured by comprehensive ophthalmic exam.	12 Months
Secondary	A secondary outcome is assessment of visual acuity.	Secondary outcome is assessment of visual acuity.	12 Months
Secondary	A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).	A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).	12 Months