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

Sponsor
University Hospital, Ghent
Study ID
NCT03211741
Phase
PHASE4
Status
Completed

Conditions

  • Macular Edema
  • Retinal Neovascularization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab Injection [Avastin] — DRUG
    Bevacizumab 1.25mg/0.05 mL will be injected intravitreally using one 30-gauge x 1/2-inch injection needle vials are for single eye use only.

Study Details

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.

Key Dates

First listed
Jul 7, 2017
Start date
Nov 22, 2013
Status verified
Sep 2026
Primary completion
Jul 9, 2024
Completion
Jul 9, 2024

Study Design

Enrollment
583 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: open label

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: every visit, up to ten years ]

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