Trial Search Results

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

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)

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Aerie Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • 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:

Phase 1

Eligibility


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)

   4. 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)

   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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting