Aflibercept in Recurrent or Persistent CNV

Diabetic Macular Edema Clinical Trial

— OPHTH-010915  

Official title:

Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669953
• Other study ID #: OPHTH-010915 (Ex-Oct)
• Status: Recruiting
• Start date: December 2015
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Medical University of Vienna
• Contact: Reinhard Told, MD, PhD
• Phone: +43140400
• Email: reinhard.told[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Aflibercept

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in Best-Corrected Visual Acuity (BCVA)		After one year compared to baseline
Primary	Anatomic changes in the macula as assessed with OCT (central retinal thickness, morphologic changes, fundus photos)		after one year compared to baseline
Secondary	Number of retreatments		after one year