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

Wet Macular Degeneration Clinical Trial

— MACBETH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896284
• Other study ID #: BMF-AFLI-2013-01
• Secondary ID: 2013-000848-26
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Barcelona Macula Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• 0.5mg aflibercept
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.

Locations

Country	Name	City	State
Spain	Barcelona Macula Foundation	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Barcelona Macula Foundation	Bayer, TFS Trial Form Support

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in best corrected visual acuity (BCVA)after loading dose		week 12
Secondary	Changes in OCT central foveal thickness after loading dose		week 12
Secondary	Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.		week 40
Secondary	Determine the time to resolution of any intra/sub retinal fluid on OCT		week 4,8,12,24,32,40
Secondary	Describe safety of this cohort of patients	Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks	baseline, week 4, 8, 12, 24, 32 and 40