Trial Outcomes & Findings for Study for Recalcitrant Age Related Macular Degeneration (NCT NCT01543568)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

6 months

Results posted on

2017-01-02

Participant Flow

Patients were recruited from March 2012 to September 2012. 50 subjects from 1 site of the United States from a medical clinic. Each subject was was over 50 years of age, diagnosed with choroidal neovascularization secondary to AMD, and had a history of treatment with 0.5 mg ranibizumab followed by 2.0 mg ranibizumab for AMD.

Participant milestones

Participant milestones
Measure	2.0 mg Intravitreal Aflibercept open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Overall Study STARTED	46
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study for Recalcitrant Age Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	41 Participants n=99 Participants
Age, Continuous	77.8 years n=99 Participants
Gender Female	24 Participants n=99 Participants
Gender Male	22 Participants n=99 Participants
Region of Enrollment United States	46 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
The Number of Patients With no Fluid on OCT	10 participants

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Mean Change in OCT Central Foveal Thickness	-27.3 micrometers Interval -381.0 to 59.0

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT	4 months Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
The Percentage of Patients Who Lose > 15 Letters Visual Acuity	0 Percentage of patients

SECONDARY outcome

Timeframe: 6 Months

Change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to month 6. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Outcome measures

Outcome measures
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Mean Change in Visual Acuity (BCVA)	0.2 ETDRS BCVA letters Interval -10.0 to 13.0

SECONDARY outcome

Timeframe: 6 Months

Population: Given lack of visual benefit upon switching to aflibercept (Eylea), such analyses were not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 months

Outcome measures

Outcome measures
Measure	2.0 mg Intravitreal Aflibercept n=46 Participants open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Mean Number of 0.2 mg Aflibercept Injections Administered	5.6 injections Interval 4.0 to 6.0

Adverse Events

2.0 mg Intravitreal Aflibercept

Serious events: 9 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2.0 mg Intravitreal Aflibercept n=45 participants at risk open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Infections and infestations Urinary Tract Infection	4.4% 2/45
Cardiac disorders Death	2.2% 1/45
Cardiac disorders Atrial fibrillation	2.2% 1/45
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	4.4% 2/45
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	11.1% 5/45

Other adverse events

Other adverse events
Measure	2.0 mg Intravitreal Aflibercept n=45 participants at risk open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT) aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg
Eye disorders Cataract Progression	6.7% 3/45
Eye disorders Geographic atrophy progression	6.7% 3/45

Additional Information

David Brown, MD

Retina Consultants of Houston

Phone: 713-524-3434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place