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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120311
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Targeted Therapy Technologies, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Macular Edema Radiation Retinopathy Branch Retinal Vein Occlusion Epiretinal Membrane Central Serous Retinopathy With Pit of Optic Disc Commotio Retinae Vitritis Drug: Episcleral Dexamethasone Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 25, 2020
Estimated Study Completion Date : September 25, 2020


Arm Intervention/treatment
Experimental: Phase I open label study

Drug: Episcleral Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone

Other Names:

• Sustained Release Transscleral Dexamethasone

Drug: Episcleral Dexamethasone
Sustained Release Episcleral Dexamethasone
Other Names:
  • Sequestered Transscleral, Controlled-Release Dexamethasone
  • Sustained Release Transscleral Dexamethasone




Primary Outcome Measures :
  1. A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam. [ Time Frame: 12 Months ]
    Assessment of ocular safety as measured by comprehensive ophthalmic exam.


Secondary Outcome Measures :
  1. A secondary outcome is assessment of visual acuity. [ Time Frame: 12 Months ]
    Secondary outcome is assessment of visual acuity.

  2. A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT). [ Time Frame: 12 Months ]
    A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120311


Contacts
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Contact: Amy Dennis 650-497-7935 amyd05@stanford.edu
Contact: Theodore Leng, MD

Locations
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United States, California
Stanford Medicine Ophthalmology Recruiting
Palo Alto, California, United States, 94303
Contact: Amy Dennis, RN    650-497-7935    amyd05@stanford.edu   
Principal Investigator: Theodore Leng, MD         
Sponsors and Collaborators
Targeted Therapy Technologies, LLC
Investigators
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Principal Investigator: Theodore Leng, MD Stanford Medicine
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Responsible Party: Targeted Therapy Technologies, LLC
ClinicalTrials.gov Identifier: NCT04120311    
Other Study ID Numbers: 3TDEX-02
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Targeted Therapy Technologies, LLC:
Macular Edema
Radiation Retinopathy
Branch Retinal Vein Occlusion
Epiretinal Membrane
Central Serous Retinopathy with Pit of Optic Disc
Commotio Retinae
Vitritis
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Retinal Vein Occlusion
Epiretinal Membrane
Central Serous Chorioretinopathy
Edema
Macular Degeneration
Retinal Degeneration
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors