Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor

NCT01896284 | Completed Phase 4

• 2 other identifiers: BMF-AFLI-2013-012013-000848-26
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.

Conditions

Wet Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept

  At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8.

  Week 12

Secondary Outcomes (5)

• Changes in best corrected visual acuity (BCVA)after loading dose

  week 12

• Changes in OCT central foveal thickness after loading dose

  week 12

• Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.

  week 40

• Determine the time to resolution of any intra/sub retinal fluid on OCT

  week 4,8,12,24,32,40

• Describe safety of this cohort of patients

  baseline, week 4, 8, 12, 24, 32 and 40

Study Arms (1)

0.5mg AFLIBERCEPT injection

EXPERIMENTAL

Patients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32. Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection.

Drug: 0.5mg aflibercept

Interventions

0.5mg aflibercept DRUG

0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.

Also known as: EYLEA

0.5mg AFLIBERCEPT injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Men and women ≥ 50 years of age.
• Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
• Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
• Able to return for ALL clinic visits and complete all study-related procedures.
• Absence of other ocular diseases that could affect visual acuity.
• Patients without optimal response to ranibizumab or bevacizumab defined as:
• Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab.
• Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab.

You may not qualify if:

• No scar, fibrosis, or atrophy involving the center of the fovea
• No retina pigment epithelium (RPE) rip/tear involving the central fovea
• Participation in another simultaneous interventional clinical trial
• Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
• Prior treatment with photodynamic therapy (PDT)
• Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
• Active intraocular inflammation in the study eye
• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
• Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies

Sponsors & Collaborators

• Barcelona Macula Foundation: lead
• TFS Trial Form Support: collaborator
• Bayer: collaborator

Study Sites (1)

Barcelona Macula Foundation

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jordi Mones, MD PhD

  Barcelona Macula Foundation

  PRINCIPAL INVESTIGATOR

• Carlos Juan Donate, MD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• Marta Suárez de Figueroa, MD

  Hosipital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• Jose Luis Olea, MD

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Francisco Cabrera, MD

  Hospital Universitario Insular de Canarias

  PRINCIPAL INVESTIGATOR

• Laura Sarasols, MD

  Hospital Universitari General de Catalunya

  PRINCIPAL INVESTIGATOR

• Javier Araiz, MD

  Instituto Clínico Quirúrgico de Oftalmología de Bilbao

  PRINCIPAL INVESTIGATOR

• Jose Maria Ruiz-Moreno, MD

  Hospital Universitario de Albacete

  PRINCIPAL INVESTIGATOR

• Ignasi Jürgens, MD PhD

  Institut Catala de Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: November 23, 2018

Record last verified: 2015-07

Locations

ES (1)