Aflibercept in Recurrent or Persistent CNV (OPHTH-010915)

Medical University of Vienna

Status: Enrolling

Conditions: Age Related Macular Degeneration; Diabetic Macular Edema; Intravitreal Injections

Treatments: Drug: Aflibercept

Study type: Observational

Funder types: Other

Identifiers

NCT02669953

OPHTH-010915 (Ex-Oct)

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

AMD patients previously teated with Lucentis

Description:

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.

Treatment:

Drug: Aflibercept

treatment naive AMD patients

Description:

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

Treatment:

Drug: Aflibercept

DME patients previously teated with Lucentis

Description:

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;

Treatment:

Drug: Aflibercept

treatment naive DME patients

Description:

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

Treatment:

Drug: Aflibercept