Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2022-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME) or neovascular Age-Related Macular Degeneration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)

NCT04857996

Diabetic Macular Edema (DME)

COMPLETED PHASE2

Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)

NCT06011798

Diabetic Macular Edema Retinal Disease Macular Edema +6 more

COMPLETED PHASE2

Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)

NCT05275205

Neovascular Age-related Macular Degeneration

COMPLETED PHASE2

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

NCT06847854

Diabetic Macular Edema

ACTIVE_NOT_RECRUITING PHASE1

A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

NCT02555306

Age-Related Macular Degeneration

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort in order to address the primary objective. Up to an additional 6 nAMD patients will be enrolled in the highest dose cohort. A single dose of UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema Neovascular Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment with UBX1325

UBX1325, single intravitreal injection, ascending dose

Group Type EXPERIMENTAL

UBX1325

Intervention Type DRUG

Investigational drug intravitreal injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UBX1325

Investigational drug intravitreal injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* nAMD patients who, in the opinion of the Investigator, are inadequately responding to or failed current treatment options.
* Active choroidal neovascularization (CNV) associated with age-related macular degeneration as evidenced on FA and SD-OCT at Day 1, including presence of intraretinal or subretinal fluid.
* BCVA in the study eye (most affected) of 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse at screening and on Day 1.
* Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria

* Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening.
* Subretinal hemorrhage with bleeding area ≥4 disc area in the study eye
* Concomitant therapy with anti-VEGF therapies (e.g., Avastin®, Lucentis®, or Eylea®) or previous use of these agents in the study eye within approximately 28 days of study enrollment
* Any retinovascular disease or retinal degeneration other than nAMD in the study eye.
* History of systemic and intraocular steroid use for 6 months prior to Day 1. The use of intravitreal nonbiodegradable steroid implants (ex. Iluvien®, Yutiq®, Retisert®) is prohibited.
* Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging.
* Any uncontrolled medical condition that, in the opinion of the investigator, would preclude participation in this study.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No