OPHTH-010915: Aflibercept in Recurrent or Persistent CNV

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT02669953
Collaborator
(none)
80
Enrollment
1
Location
72
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Percent change in Best-Corrected Visual Acuity (BCVA) [After one year compared to baseline]

  2. Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos) [after one year compared to baseline]

Secondary Outcome Measures

  1. Number of retreatments [after one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Medical University of ViennaViennaAustria1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stefan Sacu, Prof. PD. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02669953
Other Study ID Numbers:
  • OPHTH-010915 (Ex-Oct)
First Posted:
Feb 1, 2016
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2021