NCT03835884

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2019

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2022

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

February 7, 2019

Last Update Submit

February 7, 2023

Conditions

Neovascular Age-related Macular DegenerationDiabetic Macular Edema

Keywords

Neovascular AMDDiabetic macular edemaDiabetic retinopathyVascular endothelial growth factorIntravitreal injection

Outcome Measures

Primary Outcomes (1)

  • Number of ocular and non-ocular TEAEs

    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.

    24 weeks

Study Arms (4)

AR-13503 Implant 10.6 Dose

EXPERIMENTAL

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 21.2 Dose

EXPERIMENTAL

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 42.4 Dose

EXPERIMENTAL

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 63.6 Dose

EXPERIMENTAL

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

Interventions

AR-13503 Implant 10.6 DoseDRUG

AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye

AR-13503 Implant 10.6 Dose
AR-13503 Implant 21.2 DoseDRUG

AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye

AR-13503 Implant 21.2 Dose
AR-13503 42.4 DoseDRUG

AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye

AR-13503 Implant 42.4 Dose
AR-13503 63.6 DoseDRUG

AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye

AR-13503 Implant 63.6 Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Presence of active subfoveal or juxtafoveal Choroidal Neovascularization (CNV) (any subtype) with leakage affecting the fovea secondary to Age-Related Macular Degeneration (AMD)
  • 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)
  • Able and willing to give signed informed consent and follow study instructions
  • Subjects with Diabetic Macular Edema (DME) must meet all the following criteria to enter into the study:
  • years of age or older
  • Type 1 or 2 diabetes mellitus with center-involved DME
  • 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)
  • Able and willing to give signed informed consent and follow study instructions

You may not qualify if:

  • Ophthalmic:
  • Use of intravitreal aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
  • History of vitreoretinal surgery in the study eye
  • 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
  • Any current or history of periocular or intraocular inflammation or evidence of infection in either eye
  • Media clarity insufficient to obtain quality fundus and OCT images in the study eye
  • Systemic:
  • History or current systemic condition that in the Investigator opinion preclude the safe administration of the study treatment or confound results
  • History of allergy or sensitivity to fluorescein or povidone iodine
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
  • Participation in an investigational study within 30 days of Screening
  • Ophthalmic:
  • Use of intraocular or periocular corticosteroids within 6 months, aflibercept within 8 weeks, ranibizumab or bevacizumab within 6 weeks
  • History of vitreoretinal surgery in the study eye
  • High risk proliferative diabetic retinopathy in the study eye and related complications
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Retinal Research Institute, LLC

Gilbert, Arizona, 85296, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Sterling Vision, PC dba Oregon Retina

Eugene, Oregon, 97401, United States

Location

Valley Retina Institute, P.A.

Harlingen, Texas, 78550, United States

Location

Medical Center Ophthamology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Kevin Kerr

    Aerie Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 11, 2019

Study Start

June 24, 2019

Primary Completion

May 12, 2022

Study Completion

May 12, 2022

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(6)