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Clinical Trials/EUCTR2013-001208-12-NL
EUCTR2013-001208-12-NL
Active, not recruiting
Phase 1

Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment.

Radboud University Nijmegen Medical Centre0 sites20 target enrollmentMay 17, 2013
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Conditionseovascular Age-related macular degenerationTherapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsEylea

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
eovascular Age-related macular degeneration
Sponsor
Radboud University Nijmegen Medical Centre
Enrollment
20
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 17, 2013
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Radboud University Nijmegen Medical Centre

Eligibility Criteria

Inclusion Criteria

  • •\- Patients will have received at least 6 anti\-VEGF injections within 1 year.
  • •\- Active neovascular AMD seen as leakage on FA and (sub\-) retinal fluid on OCT.
  • •\- Maximally 1 year since onset of visual complaints and start of anti\-VEGF treatment.
  • •\- Minimally 1 month and maximally 3 months between last anti\-VEGF injection and first aflibercept injection.
  • •\- Age 50 years and older
  • •\- Visual acuity at baseline between 20/25 and 20/320\.
  • •\- OCT available prior to first injection and after every three anti\-VEGF injections.
  • •\- Give written informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •\- Signs of subretinal fibrosis, scarring or geographic atrophy on OCT or FA, involving the center of the macula.
  • •\- Pigment epithelial detachment with a maximum height of \=150µm.
  • •\- Any ocular diseases beside AMD in the study eye, including myopic fundus and vitreoretinal traction.
  • •\- Myopia of 8\.00 D or more, irrespective of myopic fundus features.
  • •\- Ocular surgery of the study eye \= 2 months prior to or during the previous anti\-VEGF treatment.

Outcomes

Primary Outcomes

Not specified

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