A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema (KALAHARI)

  • STATUS
    Recruiting
  • End date
    Mar 27, 2023
  • participants needed
    126
  • sponsor
    Oxurion
Updated on 27 July 2022
diabetes
edema
vegf
type 2 diabetes mellitus
growth factor
bevacizumab
vascular endothelial growth factor
macular edema
aflibercept
diabetic macular edema
optical coherence tomography
spectral domain optical coherence tomography
sd-oct

Summary

Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Details
Condition Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
Treatment Aflibercept, THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3, THR-149 selected dose level, THR-149 0.13mg, THR-149 0.13mg + aflibercept 2mg, aflibercept 2mg + THR-149 0.13mg, Aflibercept 2mg
Clinical Study IdentifierNCT04527107
SponsorOxurion
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent obtained from the subject prior to screening procedures
Male or female aged 18 years or older at the time of signing the informed consent
Type 1 or type 2 diabetes
BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
BCVA ETDRS letter score ≥ 34 in the fellow eye

Exclusion Criteria

Macular edema due to causes other than DME in the study eye
Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
Previous confounding medications / interventions, or their planned administration
Presence of neovascularisation at the disc in the study eye
Presence of iris neovascularisation in the study eye
Uncontrolled glaucoma in the study eye
Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
Untreated Diabetes Mellitus
Glycated haemoglobin A (HbA1c) > 12%
Uncontrolled hypertension
Clear my responses

How to participate?

Step 1 Connect with a study center
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

Primary Contact

site

0/250

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...

Browse trials for

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