Recruiting PHASE3 Wet Age-related Macular Degeneration

New treatment option for Wet Age-related Macular Degeneration

Official title Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)

ClinicalTrials.gov ID: NCT06952452

What this study is testing

What is Bevacizumab?

Bevacizumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for wet age-related macular degeneration.

Also referred to as Avastin, L01XC07.

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 phase III, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. It will be performed involving 630 eyes from patients with wet age-related macular degeneration (wAMD) diagnosis without another eye disease.
  • 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 50 and older

You may be able to join if

  • Patients diagnosed with neovascular Age-related Macular Degeneration
  • Age of 50 years or older.
  • That at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-VEGF agent as usual in clinical practice.
  • Without previous treatment in the eye under study (no previous treatment for AMD).

You likely can't join if

  • Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
  • Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the...
  • Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
  • High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute...
  • Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe...
  • Hypersensitivity to the active substance or to the excipients.
See the full eligibility criteria
Who can join
  • Patients diagnosed with neovascular Age-related Macular Degeneration
  • Age of 50 years or older.
  • That at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-VEGF agent as usual in clinical practice.
  • Without previous treatment in the eye under study (no previous treatment for AMD).
What rules you out
  • Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
  • Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
  • Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
  • High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major...
  • Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment...
  • Hypersensitivity to the active substance or to the excipients.
  • Diabetic retinopathy documented.
  • Pregnant or nursing (lactating) women. Patients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up, collecting saliva for the analysis...

The study team makes the final eligibility decision.

Where it's taking place

  • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
  • Barcelona, Spain
  • Madrid, Spain

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, 50 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain; Barcelona, Spain; Madrid, Spain. 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.