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Trial record 1 of 1 for:    AR-13503-CS201
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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 : December 3, 2020
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: Aflibercept Other: Sham 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)
Estimated Enrollment : 59 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


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 as 1 intravitreal injection of 42.4 µg (4 implants) and 1 intravitreal injection of 21.2 µg (2 implants) into a single eye of up to 5 subjects (DME) who will be followed for 24 weeks. Subjects with central subfield thickness (CST) ≥ 300 μm (assessed at Week 12) will receive a repeat 63.6 μg treatment at Week 12, assuming absence of a dose-limiting toxicity (DLT) identified in the Week 4 Data Monitoring Committee (DMC) review.
 Drug: AR-13503 63.6 Dose
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
Experimental: AR-13503 Implant 63.6 Dose plus Aflibercept
Dose of AR-13503 Implant 63.6 Dose (63.6 μg), administered as 1 intravitreal injection of 42.4 μg (4 implants) and 1 intravitreal injection of 21.2 μg (2 implants) at Baseline (Day 0) into a single eye of 12 subjects (DME) who will be followed for 24 weeks. One intravitreal injection of aflibercept at Baseline (Day 0), Week 8, and Week 16. Repeat treatment of AR-13503 SR Implant (63.6 μg) at Week 12 if both of the following apply: a) subject has CST ≥ 300 μm (assessed by SD-OCT and confirmed by the Investigator at Week 12), and b) repeat treatment is cleared by the DMC. Note that this arm will be updated pending DMC decision.
 Drug: Aflibercept
Intravitreal Injection

Drug: AR-13503 63.6 Dose
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
Experimental: AR-13503 Implant 63.6 Dose plus Sham
Dose of AR-13503 Implant 63.6 Dose (63.6 μg), administered as 1 intravitreal injection of 42.4 μg (4 implants) and 1 intravitreal injection of 21.2 μg (2 implants) at Baseline (Day 0) into a single eye of 12 subjects (DME) who will be followed for 24 weeks. One intravitreal injection of aflibercept at Baseline (Day 0), Week 8, and Week 16. Two sham treatments at Week 12 if both of the following apply: a) subject has CST ≥ 300 μm (assessed by SD-OCT and confirmed by the Investigator at Week 12), and b) repeat treatment is cleared by the DMC. Note that this arm will be updated pending DMC decision.
 Other: Sham
Sham injection (Touch eye only; no injection)

Drug: AR-13503 63.6 Dose
AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
Experimental: 2 Sham plus Aflibercept
Two sham treatments at Baseline (Day 0) into a single eye of 12 subjects who will be followed for 24 weeks. One intravitreal injection of aflibercept at Baseline (Day 0), Week 8, and Week 16. Two sham treatments at Week 12 if both of the following apply: a) subject has CST ≥ 300 μm (assessed by SD-OCT and confirmed by the Investigator at Week 12), and b) repeat treatment is cleared by the DMC. Note that this arm will be updated pending DMC decision.
 Drug: Aflibercept
Intravitreal Injection

Other: Sham
Sham injection (Touch eye only; no injection)
Experimental: AR-13503 Implant 42.4 Dose plus Aflibercept
Dose of AR-13503 Implant 42.4 Dose (42.4 μg), administered as 1 intravitreal injection of 42.4 μg (4 implants) at Baseline (Day 0) into a single eye of 12 subjects (DME) who will be followed for 24 weeks. One intravitreal injection of aflibercept at Baseline (Day 0), Week 8, and Week 16. Note that this arm will be updated pending DMC decision.
 Drug: Aflibercept
Intravitreal Injection

Drug: AR-13503 42.4 Dose
AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
Experimental: 1 Sham plus Aflibercept
One sham treatment at Baseline (Day 0) into a single eye of 12 subjects who will be followed for 24 weeks. One intravitreal injection of aflibercept at Baseline (Day 0), Week 8, and Week 16. Note that this arm will be updated pending DMC decision.
 Drug: Aflibercept
Intravitreal Injection

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


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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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 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


Contacts
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Contact: Nancy Ramirez, MS 8885945111 nramirez@aeriepharma.com
Contact: Cathy Walter 8885945111 cwalter@aeriepharma.com

Locations
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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: December 3, 2020
Last Verified: May 2020
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