Aflibercept in Recurrent or Persistent CNV

Sponsor
Medical University of Vienna
Study ID
NCT02669953
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

Study Details

Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process. The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy. 20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up. Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) \& red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).

Key Dates

Start date
Dec 31, 2015
Status verified
Nov 2024
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: AMD patients previously teated with Lucentis
    Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form; The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria.
  • Arm: treatment naive AMD patients
    Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
  • Arm: DME patients previously teated with Lucentis
    Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
  • Arm: treatment naive DME patients
    Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;

Primary Outcome Measure

Percent change in Best-Corrected Visual Acuity (BCVA) [ Time Frame: After one year compared to baseline ]

Central Contacts

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