A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

Last updated: August 26, 2024
Sponsor: EyeBiotech Ltd.
Overall Status: Completed

Phase

1/2

Condition

Macular Degeneration

Macular Edema

Geographic Atrophy

Treatment

EYE103

Clinical Study ID

NCT05919693
EYE103-101
  • Ages > 50
  • All Genders

Study Summary

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.

In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.

In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be willing and able to understand the study procedures and the risks involved andprovide written informed consent before the first study-related activity

≥ 50 years of age

  • Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMDpatients can be either treatment naïve or treatment experienced.

  • DME patients must have vision loss in the study eye

  • NVAMD patients can be either treatment-naïve or treatment experienced with visionloss in the study eye

Exclusion

Exclusion Criteria:

  • Be pregnant or breastfeeding

  • History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening

  • Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening

  • Any other condition except for DME or NVAMD or that could affect interpretation ofstudy assessments

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: EYE103
Phase: 1/2
Study Start date:
June 12, 2023
Estimated Completion Date:
August 26, 2024

Study Description

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.

In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.

In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

Connect with a study center

  • Ciudad Autonoma Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1121ABB
    Argentina

    Site Not Available

  • Caba, Argentina

    Caba, 1023
    Argentina

    Site Not Available

  • Arecibo, PR

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • London, England

    London, England NW10 7NS
    United Kingdom

    Site Not Available

  • London, UK

    London, W1G7LB
    United Kingdom

    Site Not Available

  • Phoenix, AZ

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Bakersfield, CA

    Bakersfield, California 93309
    United States

    Site Not Available

  • Modesto, CA

    Modesto, California 95356
    United States

    Site Not Available

  • Mountain View, CA

    Mountain View, California 94040
    United States

    Site Not Available

  • Sacramento, CA

    Sacramento, California 95825
    United States

    Site Not Available

  • Colorado Springs, Colorado

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Lakewood, CO

    Lakewood, Colorado 80288
    United States

    Site Not Available

  • Pompano Beach

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Lemont, NV

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Hagerstown, MD

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Reno, NV

    Reno, Nevada 89502
    United States

    Site Not Available

  • West Columbia, SC

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Germantown, TN

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Knoxville, TN

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Nashville, TN

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Abilene, TX

    Abilene, Texas 79606
    United States

    Site Not Available

  • Amarillo, TX

    Amarillo, Texas 79109
    United States

    Site Not Available

  • Austin, TX

    Austin, Texas 78705
    United States

    Site Not Available

  • Bellaire, TX

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dallas, TX

    Dallas, Texas 75231
    United States

    Site Not Available

  • Katy, TX

    Katy, Texas 77494
    United States

    Site Not Available

  • McAllen, TX

    McAllen, Texas 78503
    United States

    Site Not Available

  • Plano, TX

    Plano, Texas 75075
    United States

    Site Not Available

  • Round Rock, TX

    Round Rock, Texas 78681
    United States

    Site Not Available

  • San Antonio, TX

    San Antonio, Texas 78240
    United States

    Site Not Available

  • The Woodlands, TX

    The Woodlands, Texas 77384
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.