A Study Assessing AR-13503 Implant in Subjects With nAMD or DME

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03835884

Collaborator

(none)

Enrollment

Locations

Arms

32.9

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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: 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

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Masking Description:

No masking

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 :

Aug 16, 2019

Actual Primary Completion Date :

May 12, 2022

Actual Study Completion Date :

May 12, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of ocular and non-ocular TEAEs [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

50 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

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:

18 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

Exclusion Criteria for Subjects with Neovascular Age-Related Macular Degeneration (nAMD)

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

Exclusion Criteria for Subjects with DME

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
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
Media clarity insufficient to obtain quality fundus and OCT images in the study eye

Systemic:

History or current medical condition that in the Investigator's 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Research Institute, LLC	Gilbert	Arizona	United States	85296
2	Retina-Vitreous Associates Medical Group	Beverly Hills	California	United States	90211
3	Bay Area Retina Associates	Walnut Creek	California	United States	94598
4	Sterling Vision, PC dba Oregon Retina	Eugene	Oregon	United States	97401
5	Valley Retina Institute, P.A.	Harlingen	Texas	United States	78550
6	Medical Center Ophthamology Associates	San Antonio	Texas	United States	78240