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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    21
  • sponsor
    Unity Biotechnology, Inc.
Updated on 27 June 2021

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.

Description

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.

Details
Condition Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment UBX1325
Clinical Study IdentifierNCT04537884
SponsorUnity Biotechnology, Inc.
Last Modified on27 June 2021

Eligibility

Yes No Not Sure

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
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
Any retinovascular disease or retinal degeneration other than nAMD in the study eye
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note