Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03835884 | Recruiting, Not yet recruiting Studies
Previous Study | Return to List | Next Study

A Study Assessing AR-13503 Implant Alone and in Combination With Aflibercept 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. 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: NCT03835884
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date August 27, 2019
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03835884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Assessing AR-13503 Implant Alone and in Combination With Aflibercept in Subjects With nAMD or DME
Official Title  ICMJE 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)
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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Masking Description:
No masking (stage 1) and participant (Stage 2)
Primary Purpose: Treatment
Condition  ICMJE
  • Neovascular Age-related Macular Degeneration
  • Diabetic Macular Edema
Intervention  ICMJE
  • Drug: AR-13503 Implant Low Dose
    AR-13503 Implant Low Dose (10.6 µg) administered as an intravitreal implant into a single eye
  • 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
  • Other: Sham
    Sham injection (Touch eye only; no injection)
Study Arms  ICMJE
  • 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
    Intervention: Drug: AR-13503 Implant Low Dose
  • 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
    Intervention: Drug: AR-13503 Implant High Dose
  • 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
    Interventions:
    • Drug: AR-13503 Implant Low Dose
    • Drug: Aflibercept
  • 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
    Interventions:
    • Drug: AR-13503 Implant High Dose
    • Drug: Aflibercept
  • 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
    Interventions:
    • Drug: AR-13503 Implant Low Dose
    • Other: Sham
  • 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
    Interventions:
    • Drug: AR-13503 Implant High Dose
    • Other: Sham
  • 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
    Interventions:
    • Drug: Aflibercept
    • Other: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nancy Ramirez, MS 8885945111 nramirez@aeriepharma.com
Contact: Puiwah Braswell 8885945111 pbraswell@aeriepharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03835884
Other Study ID Numbers  ICMJE AR-13503-CS201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aerie Pharmaceuticals
Study Sponsor  ICMJE Aerie Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Herring Aerie Pharmaceuticals, Inc.
PRS Account Aerie Pharmaceuticals
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP