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RecruitingNCT02669953OPHTH-010915Updated Nov 26, 2024

Aflibercept in Recurrent or Persistent CNV

An observational study in Age Related Macular Degeneration, Intravitreal Injections and Diabetic Macular Edema, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Medical University of Vienna · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
50 Years and older
Sex
All
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Study summary

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).

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Conditions studied

  • Age Related Macular Degeneration
  • Intravitreal Injections
  • Diabetic Macular Edema
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In context

Macular Degeneration

1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.

This study's planned enrollment of 80 is below the median of 106 across 427 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.

Browse Medical University of Vienna studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

20 Patients with nAMD

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adults ≥ 50 years

  • Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year
  • BCVA >= 20/400 in the study eye using ETDRS
  • Willingness and ability to comply with regular visits
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Any surgical treatment of the eye within 3 months prior to baseline in the study eye
  • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
  • Aphakia or absence of the posterior capsule (excluding YAG-capsulotomy) in the study eye
  • Retinal pigment epithelial tear involving the macula in the study eye
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Aflibercept

  • treatment naive AMD patients

    Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;

    Drug: Aflibercept

  • 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;

    Drug: Aflibercept

  • treatment naive DME patients

    Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;

    Drug: Aflibercept

Interventions

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What researchers measure

Primary outcomes

  1. Percent change in Best-Corrected Visual Acuity (BCVA)

    Time frame: After one year compared to baseline

  2. Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos)

    Time frame: after one year compared to baseline

Secondary outcomes

  1. Number of retreatments

    Time frame: after one year

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Study locations

1 of 1 sites recruiting
  • Medical University of Vienna
    Vienna, 1090, Austria
    • Reinhard Told, MD, PhD · Contact · +43140400
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of Nov 2025 and a completion of Dec 2025. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2016
First posted
Feb 1, 2016
Start
Dec 2015
Primary completionEst.
Nov 2025
CompletionEst.
Dec 2025
Last update
Nov 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02669953
Lead sponsor
Medical University of Vienna
Responsible party
Stefan Sacu (Prof. PD. Dr., Medical University of Vienna) — Principal investigator
First posted
Feb 1, 2016
Start date
Dec 2015
Primary completion
Nov 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Reinhard Told, MD, PhD
Contact
reinhard.told@meduniwien.ac.at
+43140400 ext. 48470
Stefan Sacu, Prof. PD. MD
Contact
stefan.sacu@meduniwien.ac.at
+43140400 ext. 48470

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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