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A Study Assessing AR-13503 Implant in Subjects With nAMD or DME

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835884
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Study Description
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Brief Summary:
First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Diabetic Macular Edema Drug: AR-13503 Implant 10.6 Dose Drug: AR-13503 Implant 21.2 Dose Drug: AR-13503 42.4 Dose Drug: AR-13503 63.6 Dose Phase 1

Detailed Description:
This is a first-in-human study conducted in 2 sequential stages; each stage is 24 weeks in duration. Subjects with nAMD and subjects with DME were evaluated in Stage 1. Subjects with DME will be evaluated in Stage 2.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: First-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) and Subjects With Diabetic Macular Edema (DME)
Actual Study Start Date : August 16, 2019
Actual Primary Completion Date : May 12, 2022
Actual Study Completion Date : May 12, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AR-13503 Implant 10.6 Dose
Single dose of AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks
 Drug: AR-13503 Implant 10.6 Dose
AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye
Experimental: AR-13503 Implant 21.2 Dose
Single dose of AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks
 Drug: AR-13503 Implant 21.2 Dose
AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
Experimental: AR-13503 Implant 42.4 Dose
Single dose of AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye of up to 6 subjects (3 nAMD and 3 DME) who will be followed for 24 weeks
 Drug: AR-13503 42.4 Dose
AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
Experimental: AR-13503 Implant 63.6 Dose
Dose of AR-13503 Implant 63.6 Dose (63.6 µg) administered into a single eye of up to 5 subjects (DME) who will be followed for 24 weeks. Subjects may qualify to receive an additional dose at Week 12.
 Drug: AR-13503 63.6 Dose
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye


Outcome Measures
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Primary Outcome Measures :
  1. Number of ocular and non-ocular TEAEs [ Time Frame: 24 weeks ]
    Number of ocular and non-ocular treatment-emergent adverse events (TEAEs), summarized at the subject level by system organ class and preferred term, and also by severity and relatedness to treatment.


Eligibility Criteria
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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 for Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

  1. 50 years of age or older
  2. Presence of active subfoveal or juxtafoveal Choroidal Neovascularization (CNV) (any subtype) with leakage affecting the fovea secondary to Age-Related Macular Degeneration (AMD)

  3. Best Corrected Visual Acuity (BCVA) in the study eye at Baseline (Day 0):

    Stage 1: between 65 and 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/50 and 20/640 Snellen equivalent)

  4. Able and willing to give signed informed consent and follow study instructions

Inclusion Criteria for Subjects with Diabetic Macular Edema (DME)

Subjects with Diabetic Macular Edema (DME) must meet all the following criteria to enter into the study:

  1. 18 years of age or older
  2. Type 1 or 2 diabetes mellitus with center-involved DME

  3. BCVA in the study eye at Baseline (Day 0):

    Stage 1: between 65 and 10 ETDRS letters (20/50 and 20/640 Snellen equivalent) Stage 2: between 70 and 20 ETDRS letters (20/40 and 20/400 Snellen equivalent)

  4. Able and willing to give signed informed consent and follow study instructions

Exclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

Ophthalmic:

  1. Use of intravitreal aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
  2. History of vitreoretinal surgery in the study eye
  3. Any ocular disease in the study eye that in the Investigator and Reading Center's opinion may confound assessment of the macula, affect central vision, confound results, or preclude improvement in visual acuity
  4. Any current or history of periocular or intraocular inflammation or evidence of infection in either eye
  5. Media clarity insufficient to obtain quality fundus and OCT images in the study eye

Systemic:

  1. History or current systemic condition that in the Investigator opinion preclude the safe administration of the study treatment or confound results
  2. History of allergy or sensitivity to fluorescein or povidone iodine
  3. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  4. Participation in an investigational study within 30 days of Screening

Exclusion Criteria for Subjects with DME

Ophthalmic:

  1. Use of intraocular or periocular corticosteroids within 6 months, aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
  2. History of vitreoretinal surgery in the study eye
  3. High risk proliferative diabetic retinopathy in the study eye and related complications
  4. Structural damage to the center or the macula that is likely to preclude improvement in visual acuity in the study eye after resolution of the DME
  5. Media clarity insufficient to obtain quality fundus and OCT images in the study eye

Systemic:

  1. History or current medical condition that in the Investigator's opinion preclude the safe administration of the study treatment or confound results
  2. History of allergy or sensitivity to fluorescein or povidone iodine
  3. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  4. Participation in an investigational study within 30 days of Screening
Contacts and Locations
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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): NCT03835884


Locations
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United States, Arizona
Retinal Research Institute, LLC
Gilbert, Arizona, United States, 85296
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Oregon
Sterling Vision, PC dba Oregon Retina
Eugene, Oregon, United States, 97401
United States, Texas
Valley Retina Institute, P.A.
Harlingen, Texas, United States, 78550
Medical Center Ophthamology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Kevin Kerr Aerie Pharmaceuticals, Inc.
More Information
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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03835884    
Other Study ID Numbers: AR-13503-CS201
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
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
Keywords provided by Aerie Pharmaceuticals:
Neovascular AMD
Diabetic macular edema
Diabetic retinopathy
Vascular endothelial growth factor
Intravitreal injection
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Wet Macular Degeneration
Edema
 Retinal Degeneration
Retinal Diseases
Eye Diseases