Clinical trial NCT05919693: 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)
Official title: A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration (NVAMD)
Diabetic Macular Edema (DME)
Keywords: Neovascular Age-related Macular Degeneration (NVAMD)
Diabetic Macular Edema (DME)
Age-related Macular Degeneration (AMD)
Lead sponsor: EyeBiotech Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1 is a multiple-dose escalation study and patients will be enrolled sequentially in ascending order through the dose levels until the highest level is reached or until a maximum tolerated dose is reached, whichever comes first.

Part 2 is randomized single-masked study where patients on all arms will be enrolled in parallel.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 3 months
Secondary outcomes:
measure: Best-corrected Visual Acuity
timeFrame: 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix, AZ
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield, CA
state: California
city: Modesto
country: United States
facility: Modesto, CA
state: California
city: Mountain View
country: United States
facility: Mountain View, CA
state: California
city: Sacramento
country: United States
facility: Sacramento, CA
state: California
city: Sacramento
country: United States
facility: Sacramento, CA
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs, Colorado
state: Colorado
city: Lakewood
country: United States
facility: Lakewood, CO
state: Colorado
city: Pompano Beach
country: United States
facility: Pompano Beach
state: Florida
city: Lemont
country: United States
facility: Lemont, NV
state: Illinois
city: Hagerstown
country: United States
facility: Hagerstown, MD
state: Maryland
city: Reno
country: United States
facility: Reno, NV
state: Nevada
city: West Columbia
country: United States
facility: West Columbia, SC
state: South Carolina
city: Germantown
country: United States
facility: Germantown, TN
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville, TN
state: Tennessee
city: Nashville
country: United States
facility: Nashville, TN
state: Tennessee
city: Abilene
country: United States
facility: Abilene, TX
state: Texas
city: Amarillo
country: United States
facility: Amarillo, TX
state: Texas
city: Austin
country: United States
facility: Austin, TX
state: Texas
city: Bellaire
country: United States
facility: Bellaire, TX
state: Texas
city: Dallas
country: United States
facility: Dallas, TX
state: Texas
city: Katy
country: United States
facility: Katy, TX
state: Texas
city: McAllen
country: United States
facility: McAllen, TX
state: Texas
city: Plano
country: United States
facility: Plano, TX
state: Texas
city: Round Rock
country: United States
facility: Round Rock, TX
state: Texas
city: San Antonio
country: United States
facility: San Antonio, TX
state: Texas
city: The Woodlands
country: United States
facility: The Woodlands, TX
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Ciudad Autonoma Buenos Aires
state: Buenos Aires
city: Caba
country: Argentina
facility: Caba, Argentina
city: Arecibo
country: Puerto Rico
facility: Arecibo, PR
city: London
country: United Kingdom
facility: London, England
state: England
city: London
country: United Kingdom
facility: London, UK
Study officials:
References: