Comparing AVT29 and Eylea HD for diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, double-masked, parallel-group multicenter study compares the efficacy and safety of AVT29 (a proposed aflibercept HD biosimilar) with Eylea HD in adults with center-involving diabetic macular edema. Eligible participants are adults with vision between 73 and 34 ETDRS letters in the study eye and who have not previously received anti-VEGF therapy. Participants are randomized to receive one of the two injections and followed with standardized visual acuity and safety assessments over the study period. The trial's primary focus is on visual acuity outcomes and adverse events to determine whether AVT29 provides comparable benefit and tolerability to Eylea HD.

Why it matters

Who can join: the full rules

Main Inclusion Criteria:

* Participant is ≥18 years old at the time of signing the ICF.
* Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.
* Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.
* Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.
* Participant's decrease in vision is determined to be primarily the result of DME in the study eye.

Main Exclusion Criteria:

* previous treatment with anti-VEGF therapy
* history or concurrent disease other than DME that could compromise visual acuity
* Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data
* participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.

Where it's running

• Site 3004
  Budapest, Hungary Recruiting

Study contacts

• Study coordinator: Silvia Cirillo
• Email: alvotech.clinical@alvotech.com
• Phone: +41 78 659 89 89

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

  This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.

  Recruiting Fatih Sultan Mehmet Training and Research Hospital · Istanbul · NCT07821450

• Testing Different Doses of BI 3812465 in Diabetic Macular Edema

  Researchers are testing whether varying doses of BI 3812465 can be tolerated in adults with center-involved diabetic macular edema.

  Recruiting at 26 sites Phase 1/2 Boehringer Ingelheim · Phoenix, Arizona and 28 other locations · NCT07553429

• Daily oral Kamuvudine-9 (K9) for diabetic macular edema

  This trial will test whether taking oral K9 twice daily is safe and improves vision in adults with diabetic macular edema.

  Recruiting Phase 1/2 Vistar Eye Center · Roanoke, Virginia · NCT07458061

• RO7823653 injections, alone or with faricimab, for diabetic macular edema

  This research tests injections of RO7823653, given alone or with faricimab, in people with diabetic macular edema to see if the medication is safe and how the eye handles it.

  Recruiting at 12 sites Phase 1 Genentech, Inc. · Peoria, Arizona and 11 other locations · NCT07425522

• Lactobacillus plantarum 299v Probiotic for Diabetic Macular Edema

  A probiotic pill taken twice daily for four months is tested to see if it can help people with diabetic macular edema see better or need fewer eye injections.

  Recruiting Phase 2 Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT07383701

• Early progression of non-center diabetic macular edema after phacoemulsification

  This will see if non-center-involving diabetic macular edema worsens in the early weeks after cataract surgery in adults with diabetes.

  Recruiting Ain Shams University · Cairo · NCT07038967

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.