Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05919693
Other study ID # EYE103-101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 12, 2023
Est. completion date December 31, 2024

Study information

Verified date July 2023
Source EyeBiotech Ltd.
Contact Keith Baker, MD
Phone 212-914-0127
Email ClinicalInquiries@eyebiotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 92
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity - DME patients must be = 18 years of age, NVAMD patients must be = 50 years of age - Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients 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 vision loss in the study eye 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 of study assessments

Study Design


Intervention

Drug:
EYE103
EYE103 is a humanized antibody formulated for IVT administration

Locations

Country Name City State
Argentina Caba, Argentina Caba
Argentina Ciudad Autonoma Buenos Aires Ciudad Autonoma de Buenos Aires Buenos Aires
Puerto Rico Arecibo, PR Arecibo
United Kingdom London, England London England
United Kingdom London, UK London
United States Abilene, TX Abilene Texas
United States Amarillo, TX Amarillo Texas
United States Austin, TX Austin Texas
United States Bakersfield, CA Bakersfield California
United States Bellaire, TX Bellaire Texas
United States Colorado Springs, Colorado Colorado Springs Colorado
United States Dallas, TX Dallas Texas
United States Germantown, TN Germantown Tennessee
United States Hagerstown, MD Hagerstown Maryland
United States Katy, TX Katy Texas
United States Knoxville, TN Knoxville Tennessee
United States Lakewood, CO Lakewood Colorado
United States Lemont, NV Lemont Illinois
United States McAllen, TX McAllen Texas
United States Modesto, CA Modesto California
United States Mountain View, CA Mountain View California
United States Nashville, TN Nashville Tennessee
United States Phoenix, AZ Phoenix Arizona
United States Plano, TX Plano Texas
United States Pompano Beach Pompano Beach Florida
United States Reno, NV Reno Nevada
United States Round Rock, TX Round Rock Texas
United States Sacramento, CA Sacramento California
United States Sacramento, CA Sacramento California
United States San Antonio, TX San Antonio Texas
United States The Woodlands, TX The Woodlands Texas
United States West Columbia, SC West Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
EyeBiotech Ltd.

Countries where clinical trial is conducted

United States,  Argentina,  Puerto Rico,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Adverse Events 3 months
Secondary Best-corrected Visual Acuity Best-corrected Visual Acuity 3 months
See also
  Status Clinical Trial Phase
Completed NCT01702441 - Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema Phase 1/Phase 2
Active, not recruiting NCT04543331 - Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema
Completed NCT02424019 - Phase 4 IOP Signals Associated With ILUVIEN® Phase 4
Completed NCT02633852 - Multicenter Study to Evaluate the Efficacy of Treat and Extend Regimen of Aflibercept (EYLEA) as a Second Line Treatment for Diabetic Macular Edema Phase 4
Completed NCT04857996 - Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD) Phase 2
Completed NCT04739306 - Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema Phase 3
Recruiting NCT06116916 - Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema Phase 2
Completed NCT02050828 - The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema Phase 2
Recruiting NCT03859245 - Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention N/A
Completed NCT02585401 - Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada N/A
Terminated NCT02080091 - Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies N/A
Terminated NCT04697758 - Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema Phase 1/Phase 2
Terminated NCT00936520 - SAR 1118 in Human Subjects Undergoing Pars Plana Vitrectomy Phase 1
Not yet recruiting NCT06398080 - An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
Active, not recruiting NCT05989126 - Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS) Phase 3