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A Study Assessing AR-13503 Implant Alone and in Combination With Aflibercept in Subjects With nAMD or DME

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ClinicalTrials.gov Identifier: NCT03835884
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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 Low Dose Drug: AR-13503 Implant High Dose Drug: Aflibercept Other: Sham Phase 1

Detailed Description:
This is a first-in-human 24-week study conducted in 2 sequential stages. Stage 1 is a multicenter, open label study of the safety and tolerability of a single intravitreal administration of AR-13503 SR Implant in escalating doses and Stage 2 is a multicenter, single masked, randomized, parallel group study of the safety and preliminary response of AR-13503 SR Implant alone and in combination with aflibercept compared with aflibercept alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Masking Description: No masking (stage 1) and participant (Stage 2)
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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AR-13503 Implant Low Dose
Single dose of AR-13503 Implant Low 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 Low Dose
AR-13503 Implant Low Dose (10.6 µg) administered as an intravitreal implant into a single eye

Experimental: AR-13503 Implant High Dose
Single dose of AR-13503 Implant High Dose (21.2 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 High Dose
AR-13503 Implant High Dose (21.2 µg) administered as an intravitreal implant into a single eye

Experimental: AR-13503 Implant Low Dose + Aflibercept
Single dose of AR-13503 Implant Low Dose (10.6 µg) administered as an intravitreal implant plus intravitreal injections of aflibercept into a single eye of up to 18 subjects (9 nAMD and 9 DME) who will be followed for 24 weeks
Drug: AR-13503 Implant Low Dose
AR-13503 Implant Low Dose (10.6 µg) administered as an intravitreal implant into a single eye

Drug: Aflibercept
Intravitreal Injection

Experimental: AR-13503 Implant High Dose + Aflibercept
Single dose of AR-13503 Implant High Dose (21.2 µg) administered as an intravitreal implant plus intravitreal injections of aflibercept into a single eye of up to 18 subjects (9 nAMD and 9 DME) who will be followed for 24 weeks
Drug: AR-13503 Implant High Dose
AR-13503 Implant High Dose (21.2 µg) administered as an intravitreal implant into a single eye

Drug: Aflibercept
Intravitreal Injection

Experimental: AR-13503 Implant Low Dose + sham
Single dose of AR-13503 Implant Low Dose (10.6 µg) administered as an intravitreal implant plus sham injections (touch eye only; no injection) into a single eye of up to 18 subjects (9 nAMD and 9 DME)who will be followed for 24 weeks
Drug: AR-13503 Implant Low Dose
AR-13503 Implant Low Dose (10.6 µg) administered as an intravitreal implant into a single eye

Other: Sham
Sham injection (Touch eye only; no injection)

Experimental: AR-13503 Implant High Dose + sham
Single dose of AR-13503 Implant High Dose (21.2 µg) administered as an intravitreal implant plus sham injections (touch eye only; no injection) into a single eye of up to 18 subjects (9 nAMD and 9 DME) who will be followed for 24 weeks
Drug: AR-13503 Implant High Dose
AR-13503 Implant High Dose (21.2 µg) administered as an intravitreal implant into a single eye

Other: Sham
Sham injection (Touch eye only; no injection)

Experimental: Sham + Aflibercept
Sham injection (touch eye only; no injection) plus intravitreal injections of Aflibercept into a single eye of up to 18 subjects (9 nAMD and 9 DME) who will be followed for 24 weeks
Drug: Aflibercept
Intravitreal Injection

Other: Sham
Sham injection (Touch eye only; no injection)




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.



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 for Subjects with Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

  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) Stage 2: between 65 and 20 ETDRS letters (20/50 and 20/400 Snellen equivalent)

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

Inclusion Criteria for Subjects with 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 65 and 20 ETDRS letters (20/50 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

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


Contacts
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Contact: Nancy Ramirez, MS 8885945111 nramirez@aeriepharma.com
Contact: Puiwah Braswell 8885945111 pbraswell@aeriepharma.com

Locations
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United States, Arizona
Retinal Research Institute, LLC Not yet recruiting
Gilbert, Arizona, United States, 85296
Arizona Retina & Vitreous Consultants Not yet recruiting
Phoenix, Arizona, United States, 85021
United States, California
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Byers Eye Institute Not yet recruiting
Palo Alto, California, United States, 94303
Doheny Eye Center, UCLA Not yet recruiting
Pasadena, California, United States, 91105
Retina Consultants San Diego Not yet recruiting
Poway, California, United States, 92064
Bay Area Retina Associates Not yet recruiting
Walnut Creek, California, United States, 94598
United States, Florida
Florida Eye Clinic Recruiting
Altamonte Springs, Florida, United States, 32701
Retina Vitreous Associates of Florida Not yet recruiting
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Associates, P.L. Not yet recruiting
Tallahassee, Florida, United States, 32308
United States, New Jersey
Mid Atlantic Retina Not yet recruiting
Cherry Hill, New Jersey, United States, 08034
United States, North Carolina
Duke Eye Center Not yet recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Sterling Research Group, Ltd. Not yet recruiting
Cincinnati, Ohio, United States, 45219
Cleveland Clinic, Cole Eye Institute Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
Retina & Vitreous Center of Southern Oregon PM Recruiting
Ashland, Oregon, United States, 97520
Oregon Retina, LLP Recruiting
Eugene, Oregon, United States, 97401
Retina Northwest, P.C. Recruiting
Portland, Oregon, United States, 97221
United States, Pennsylvania
Mid Atlantic Retina Not yet recruiting
Huntingdon Valley, Pennsylvania, United States, 19006
United States, Texas
Valley Retina Institute, P.A. Recruiting
Harlingen, Texas, United States, 78550
Medical Center Ophthamology Associates Recruiting
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Mark Herring Aerie Pharmaceuticals, Inc.

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03835884     History of Changes
Other Study ID Numbers: AR-13503-CS201
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 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
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
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases