Longterm efficiency and safety of intravitreal injections with bevacizumab in patients with neovascularisation or macular edema.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005056-15-BE

Enrollment

800

Registered

2014-02-20

Start date

2014-03-21

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Choroidal neovascularisation and chronic macular edema MedDRA version: 20.0 Level: LLT Classification code 10054467 Term: Macular edema System Organ Class: 10015919 - Eye disorders MedDRA version: 21.1 Level: PT Classification code 10060823 Term: Choroidal neovascularisation System Organ Class: 10015919 - Eye disorders

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years of either gender 2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed 3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The prescence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the OCT. If both eyes are eligible for the study, both eyes can be included in the study 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mIU/mL) Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication 2. Tromboembolic event (CVA or TIA, AMI) less than 3 months prior to the intravitreal injection of bevacizumab 3. History of hypersensitivity for bevacizumab.

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available;Secondary Objective: Not applicable;Primary end point(s): to compare the results of the centre with the results of several phase 3 trials from the literature and will guide improvements in the treatment protocols.;Timepoint(s) of evaluation of this end point: This investigation will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator	—

Measure

Time frame

Main Objective: evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available;Secondary Objective: Not applicable;Primary end point(s): to compare the results of the centre with the results of several phase 3 trials from the literature and will guide improvements in the treatment protocols.;Timepoint(s) of evaluation of this end point: This investigation will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator

—

Secondary

Measure	Time frame
Secondary end point(s): Each visit, the visual acuity will be measured in the study eye with dilated fundus examination, ocular coherence tomography and fluorescein angiography;Timepoint(s) of evaluation of this end point: This investigation will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator	—

Measure

Time frame

Secondary end point(s): Each visit, the visual acuity will be measured in the study eye with dilated fundus examination, ocular coherence tomography and fluorescein angiography;Timepoint(s) of evaluation of this end point: This investigation will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator

—

Countries

Belgium

Contacts

Public ContactHIRUZ

UZ Gent

hiruz.ctu@uzgent.be003293320500

Outcome results

None listed

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