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

Phase 1

Conditions: Choroidal neovascularisation and chronic macular edema
MedDRA version: 20.0Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 21.1Level: PTClassification code 10060823Term: Choroidal neovascularisationSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-005056-15-BE

Lead Sponsor: Z Gent

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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