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Compares treatment options for Diabetic Macular Edema
Official title Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
ClinicalTrials.gov ID: NCT07489131
What this study is testing
What is AVT29 (proposed aflibercept HD biosimilar)?
AVT29 (proposed aflibercept HD biosimilar) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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...
You likely can't join if
- 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...
- participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or...
See the full eligibility criteria
- Main
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.