Clinical Study to compare the effect of AVT29 with Eylea High Dose (HD) in patients with Diabetic Macular Edema.

A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD). - Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants with Diabetic Macular Edema

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107566

Enrollment

256

Registered

2026-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H182- Other and unspecified corneal edema

Interventions

Intervention1: AVT29: AVT29 as a proposed biosimilar to Eylea 114.3 mg/mL (aflibercept). Frequency : 8mg IVT D1, W4, W8 then every 8 to 16 weeks until W48. Dose : 8 mg (0.07 mL of 114.3 mg/mL solution

Eligibility

Inclusion criteria

Inclusion criteria: As specified in Protocol Section 4.2 and 4.3 (Inclusion and Exclusion Criteria).

Exclusion criteria

Exclusion criteria: As specified in Protocol Section 4.2 and 4.3 (Inclusion and Exclusion Criteria).

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 8 in BCVA as measured by the ETDRS letter score.Timepoint: Week 8	—

Secondary

Measure	Time frame
Change from baseline in BCVA as assessed by ETDRS letter score throughout the studyTimepoint: Week 4, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, and Week 52	—

Countries

Bulgaria, Czech Republic, Georgia, Hungary, India, Latvia, Poland, Slovakia, Ukraine

Contacts

Public ContactAtaur Rahman

Syneos Health India private Limited

sumit.gupta@syneoshealth.com9560453771

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026