Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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)

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)

Details

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.

Keywords

Neovascular Age-related Macular Degeneration Diabetic Macular Edema Neovascular AMD Diabetic retinopathy Vascular endothelial growth factor Intravitreal injection Macular Degeneration Macular Edema Wet Macular Degeneration Edema AR-13503 Implant 10.6 Dose AR-13503 Implant 21.2 Dose Aflibercept AR-13503 42.4 Dose AR-13503 63.6 Dose AR-13503 Implant 42.4 Dose AR-13503 Implant 63.6 Dose AR-13503 Implant 63.6 Dose plus Aflibercept AR-13503 Implant 42.4 Dose plus Aflibercept

Eligibility

You can join if…

Open to people ages 18 years and up

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)

  1. 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)

  1. Able and willing to give signed informed consent and follow study instructions

You CAN'T join if...

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

Locations

  • Doheny Eye Center, UCLA not yet accepting patients
    Pasadena California 91105 United States
  • Retina-Vitreous Associates Medical Group accepting new patients
    Beverly Hills California 90211 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aerie Pharmaceuticals
ID
NCT03835884
Phase
Phase 1
Study Type
Interventional
Last Updated