anti-VEGF treatment in patients with diabetic macular edema

treat-and-extend regimen (TER) in patients with diabetic macular edema

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003162-82-FI

Enrollment

420

Registered

2015-07-17

Start date

2015-10-21

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Diabetic macular edema

Interventions

Trade Name: Avastin Product Name: Avastin Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18-70 years, BCVA 0.0625-0.8 Snellen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: No wet-AMD, prior anti-VEGF therapy, artery or vein occlusion, retinal ablation, optic neuropathy, glaucoma, laserphotocoagulation, endophtalmitis, myopic degeneration, other antineoplastic drugs, severe cardiovascular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Cost-benefit analysis;Secondary Objective: To optimize of anti-VEGF treatment;Primary end point(s): Best-corrected visual acuity, intraocular pressure, central retinal thickness;Timepoint(s) of evaluation of this end point: 12 months	—

Secondary

Measure	Time frame
Secondary end point(s): Number of intravitreal injections needed, central retinal thickness and area of geografic atrophy, adverse effects, and cost-benefit analysis;Timepoint(s) of evaluation of this end point: 24 months	—

Countries

Finland

Contacts

Public ContactClinical Trials Information

Raimo Tuuminen

raimo.tuuminen@helsinki.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026