Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema

University Hospital, Ghent500 enrolled

Overview

Although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions. Therefore the investigators 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. This will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Retinal Neovascularization Macular Edema

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography. If both eyes are eligible for the study, both eyes can be included in the study. 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 human chorionic gonadotropin laboratory test (\> 5mIU/mL) 2. 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 3. Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab 4. History of hypersensitivity for bevacizumab.

Outcomes

Primary Outcomes

Best Corrected Visual Acuity

will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity

Time frame: every visit, up to ten years

Slit lamp examination

will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity

Time frame: every visit, up to ten years

Dilated Fundoscopy

will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity

Time frame: every visit, up to ten years

Central Retinal Thickness

central retinal thickness as measured with the ocular coherence tomography

Time frame: annually, up to ten years

Fluorescein Angiography and Ocular Coherence Tomography

fluorescein angiography and ocular coherence tomography. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator.

Time frame: annually, up to ten years

Secondary Outcomes

side-effects

Time frame: annually, up to ten years

Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts