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

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: NCT04005430
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 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 refractory diabetic macular edema.

Condition or disease Intervention/treatment Phase
Refractory Diabetic Macular Edema 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 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.

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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: 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
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Phase 1
Phase I open label study
Drug: Episcleral Dexamethasone
Sequestered Transscleral, Controlled-Release Dexamethasone
Other Name: Sustained Release Transscleral Dexamethasone




Primary Outcome Measures :
  1. The primary outcome measure of the study is safety assessment. [ Time Frame: 12 Months ]
    The main outcome of the study is safety assessment.


Secondary Outcome Measures :
  1. Secondary outcomes are assessment of visual acuity. [ Time Frame: 12 Months ]
    Secondary outcomes are assessment of visual acuity.

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

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): NCT04005430


Contacts
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Contact: Amy Dennis 650.497.7935 amyd05@stanford.edu

Locations
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United States, California
Stanford Medicine Ophthalmology Recruiting
Palo Alto, California, United States, 94303
Contact: Amy Dennis    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: NCT04005430    
Other Study ID Numbers: 3TDEX01
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 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
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye 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
Molecular Mechanisms of Pharmacological Action