NCT04537884

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

August 28, 2020

Last Update Submit

March 8, 2022

Conditions

Diabetic Macular EdemaNeovascular Age-related Macular Degeneration

Keywords

Retinal diseaseMacular edemaDiabetes mellitusDiabetic macular edemaNeovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs)

    24 weeks

Secondary Outcomes (1)

  • Plasma concentration of UBX1325 following a single intravitreal injection

    up to 24 hours post dose

Study Arms (1)

Treatment with UBX1325

EXPERIMENTAL

UBX1325, single intravitreal injection, ascending dose

Drug: UBX1325

Interventions

UBX1325DRUG

Investigational drug intravitreal injection

Treatment with UBX1325

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Salehi Retina Institute

Huntington Beach, California, 92647, United States

Location

MedEye Associates

Miami, Florida, 33143, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

MidWest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

  • Crespo-Garcia S, Fournier F, Diaz-Marin R, Klier S, Ragusa D, Masaki L, Cagnone G, Blot G, Hafiane I, Dejda A, Rizk R, Juneau R, Buscarlet M, Chorfi S, Patel P, Beltran PJ, Joyal JS, Rezende FA, Hata M, Nguyen A, Sullivan L, Damiano J, Wilson AM, Mallette FA, David NE, Ghosh A, Tsuruda PR, Dananberg J, Sapieha P. Therapeutic targeting of cellular senescence in diabetic macular edema: preclinical and phase 1 trial results. Nat Med. 2024 Feb;30(2):443-454. doi: 10.1038/s41591-024-02802-4. Epub 2024 Feb 6.

    PMID: 38321220DERIVED

MeSH Terms

Conditions

Retinal DiseasesMacular EdemaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Eye DiseasesMacular DegenerationRetinal DegenerationGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jamie Dananberg, MD

    UNITY Biotechnology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

October 8, 2020

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(8)