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History of Changes for Study: NCT03835884
A Study Assessing AR-13503 Implant Alone and in Combination With Aflibercept in Subjects With nAMD or DME
Latest version (submitted June 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 7, 2019 None (earliest Version on record)
2 July 1, 2019 Contacts/Locations, Study Status, IPDSharing, Eligibility, Arms and Interventions, Study Design, Study Description, Oversight and Study Identification
3 August 14, 2019 Study Status
4 August 26, 2019 Recruitment Status, Study Status and Contacts/Locations
5 October 24, 2019 Contacts/Locations and Study Status
6 January 23, 2020 Study Status and Contacts/Locations
7 March 24, 2020 Arms and Interventions, Contacts/Locations, Study Status and Study Design
8 May 13, 2020 Recruitment Status, Study Status and Contacts/Locations
9 December 2, 2020 Recruitment Status, Arms and Interventions, Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
10 March 23, 2021 Contacts/Locations, Arms and Interventions, Study Design, Study Status and Study Identification
11 April 30, 2021 Study Status and Contacts/Locations
12 June 29, 2021 Study Status and Oversight
13 July 27, 2021 Contacts/Locations and Study Status
14 August 24, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
15 March 8, 2022 Study Status
16 April 19, 2022 Study Status
17 June 9, 2022 Recruitment Status, Study Status and Contacts/Locations
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Study NCT03835884
Submitted Date:  February 7, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: AR-13503-CS201
Brief Title: A Study Assessing AR-13503 Implant Alone and in Combination With Aflibercept in Subjects With nAMD or DME
Official Title: Phase 1/2a 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)
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2019
Overall Status: Not yet recruiting
Study Start: June 2019
Primary Completion: September 2021 [Anticipated]
Study Completion: September 2021 [Anticipated]
First Submitted: February 7, 2019
First Submitted that
Met QC Criteria:
February 7, 2019
First Posted: February 11, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
February 7, 2019
Last Update Posted: February 11, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Aerie Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: Phase 1/2a study to evaluate the safety and tolerability of 2 doses of AR-13503 sustained release (SR) intravitreal implant alone and in combination with aflibercept in subjects with Neovascular Age-Related Macular Degeneration (nAMD) and subject with Diabetic Macular Edema (DME).
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.
Open or close this module Conditions
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Keywords: Neovascular AMD
Diabetic macular edema
Diabetic retinopathy
Vascular endothelial growth factor
Intravitreal injection
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 7
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 102 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Low 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
Sham
Sham injection (Touch eye only; no injection)
Experimental: AR-13503 Implant High Dose + sham
Single dose of AR-13503 Implant Low 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
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
Sham
Sham injection (Touch eye only; no injection)
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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) 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 the 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
Open or close this module Contacts/Locations
Central Contact Person: Nancy Ramirez, MS
Telephone: 8885945111
Email: nramirez@aeriepharma.com
Central Contact Backup: Catherine Walter
Telephone: 8885945111
Email: cwalter@aeriepharma.com
Study Officials: Theresa Heah, MD, MBA
Study Director
Aerie Pharmaceuticals, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services