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

NCT ID: NCT04120311

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase I open label study

Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone

Other Names:

• Sustained Release Transscleral Dexamethasone

Group Type EXPERIMENTAL

Episcleral Dexamethasone

Intervention Type DRUG

Sustained Release Episcleral Dexamethasone

Interventions

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Episcleral Dexamethasone

Sustained Release Episcleral Dexamethasone

Intervention Type DRUG

Other Intervention Names

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Sequestered Transscleral, Controlled-Release Dexamethasone Sustained Release Transscleral Dexamethasone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Targeted Therapy Technologies, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theodore Leng, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Medicine

Locations

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Stanford Medicine Ophthalmology

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.

Reference Type DERIVED
PMID: 36912792 (View on PubMed)

Other Identifiers

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3TDEX-02

Identifier Type: -

Identifier Source: org_study_id