Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept

Phase 4

Completed

Conditions: Exudative Macular Degeneration

Interventions: Drug: Aflibercept

Registration Number: NCT01617148

Lead Sponsor: Rishi Singh

Brief Summary: This study will examine the use of Aflibercept in patients with exudative macular degeneration requiring intravitreal injections. Patients will be followed for 24 months. The follow up phase will be completed at month 36.

Detailed Description: The purpose of this study is to examine the use of Aflibercept in patients who have been previously treated with Ranibizumab or Bevacizumab for exudative macular degeneration. Specifically, we will examine its effect on macular degeneration, measured by SDOCT (Spectral Domain Optical Coherence Tomography) and ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity. This will be a prospective study with patients to receive an intravitreal injection of Aflibercept at the time of treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Aflibercept	Aflibercept	Subjects were given 2 mg (0.05 mL) of intravitreal aflibercept injection administered every month for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.

Primary Outcome Measures

Name	Time	Method
Change in Central Subfield Thickness From Baseline at 12 Months	baseline and 12 months	The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT

Secondary Outcome Measures

Name	Time	Method
Change in Macular Volume From Baseline at 12 Months.	baseline and 12 months	Mean absolute change from baseline in macular volume at 12 months.
Change in Best-corrected Visual Acuity From Baseline at 12 Months	Baseline and 12 months	The mean absolute change from baseline in best-corrected visual acuity score at 12 months as measured by Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) protocol. There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.
Change in Cube Average Thickness From Baseline at 12 Months	baseline and 12 months	Mean absolute change in cube average thickness as measured by SDOCT from baseline at 12 months.
Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.	baseline and 12 months	The percentage of patients who gained greater than 15 letters of vision from baseline to 12 months.
Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months	baseline and 12 months	The percentage of patients who lost greater than 15 letters of vision from baseline at 12 months.
Percentage of Subjects Who Were 20/40 or Better at Month 12.	month 12	Percentage of subjects who had vision acuity of 20/40 or better at month 12.
Percentage of Subjects Who Were 20/200 or Worse at Month 12.	month 12	Percentage of subjects who had visual acuity of 20/200 or worse at month 12.