Clinical trial NCT01896284: Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
Official title: Phase IV Study to Evaluate the Efficacy of Aflibercept in Subjects With Neovascular Age-related Macular Degeneration (wAMD), Without Optimal Response to Repeated Monthly Intravitreal Injections of Anti Vascular Endothelial Growth Factor (Anti VEGF-A) Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wet Macular Degeneration
Lead sponsor: Barcelona Macula Foundation
Sponsor class: OTHER
Collaborators: name: TFS Trial Form Support
name: Bayer
First posted: 2013-07-11
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
timeFrame: Week 12
Secondary outcomes:
measure: Changes in best corrected visual acuity (BCVA)after loading dose
timeFrame: week 12
measure: Changes in OCT central foveal thickness after loading dose
timeFrame: week 12
measure: Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.
timeFrame: week 40
measure: Determine the time to resolution of any intra/sub retinal fluid on OCT
timeFrame: week 4,8,12,24,32,40
measure: Describe safety of this cohort of patients
timeFrame: baseline, week 4, 8, 12, 24, 32 and 40
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barcelona Macula Foundation
Study officials:
affiliation: Barcelona Macula Foundation
name: Jordi Mones, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Carlos, Madrid
name: Carlos Juan Donate, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosipital Universitario Ramon y Cajal
name: Marta Suárez de Figueroa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espases
name: Jose Luis Olea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Insular de Canarias
name: Francisco Cabrera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari General de Catalunya
name: Laura Sarasols, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Clínico Quirúrgico de Oftalmología de Bilbao
name: Javier Araiz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Albacete
name: Jose Maria Ruiz-Moreno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Catala de Retina
name: Ignasi Jürgens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: