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

Primary Purpose

Wet Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

0.5mg aflibercept

About this trial

This is an interventional treatment trial for Wet Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barcelona Macula Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.5mg AFLIBERCEPT injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Changes in OCT central foveal thickness after loading dose

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

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

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

Full Information

NCT ID

NCT01896284

First Posted

July 8, 2013

Last Updated

November 21, 2018

Sponsor

Barcelona Macula Foundation

Collaborators

TFS Trial Form Support, Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01896284

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (Actual)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Barcelona Macula Foundation

Collaborators

TFS Trial Form Support, Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wet Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5mg AFLIBERCEPT injection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

0.5mg aflibercept

Other Intervention Name(s)

EYLEA

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Time Frame

week 12

Title

Changes in OCT central foveal thickness after loading dose

Time Frame

week 12

Title

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

Time Frame

week 40

Title

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

Time Frame

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

Title

Describe safety of this cohort of patients

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials: