Trial Outcomes & Findings for Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO (NCT NCT02503540)

NCT ID: NCT02503540

Last Updated: 2021-05-12

Results Overview

Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-05-12

Participant Flow

Recruitment occurred from within ophthalmology clinics.

Single arm study.

Participant milestones

Measure	Aflibercept Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Overall Study STARTED	31
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Aflibercept Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Overall Study Death	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.

Baseline characteristics by cohort

Measure	Aflibercept n=31 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Age, Continuous	67.1 years STANDARD_DEVIATION 9.7 • n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Sex: Female, Male Female	11 Participants n=29 Participants • The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Sex: Female, Male Male	18 Participants n=29 Participants • The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) Asian	0 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) Black or African American	6 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) White	23 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) More than one race	0 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Region of Enrollment United States	29 participants n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Baseline best corrected visual acuity	54.3 ETDRS letters STANDARD_DEVIATION 23.3 • n=29 Participants • The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Baseline central subfield thickness	541.2 μm STANDARD_DEVIATION 242.3 • n=29 Participants • The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Panretinal leakage index	3.4 percent STANDARD_DEVIATION 3.8 • n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Panretinal ischemic index	5.5 percent STANDARD_DEVIATION 8 • n=29 Participants • Measure Analysis Population Description: The PERMEATE study included 31 eyes. Two participants did not continue the study past month 3 because of elective study withdrawal (n = 1) and death (n = 1). Thus, 29 participants were included in the analysis.
Number of patient with visual acuity of 20/200 or worse	6 Participants n=31 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Monthly aflibercept for 6 months and then every other month for 6 months.

Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Change in Panretinal Leakage Index at Month 12 From Baseline	-3.14 percentage of region of interest in UWFA Standard Deviation 0.03

SECONDARY outcome

Timeframe: 6 months

Mean change in total leakage index from baseline to month 6

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Mean Change in Total Leakage Index	0.47 percentage of region of interest in UWFA Standard Deviation 2.0

SECONDARY outcome

Timeframe: 12 months

Change in panretinal ischemic index from baseline to postoperative month 12

Outcome measures

Measure	Aflibercept n=28 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Change in Panretinal Ischemic Index	3.2 percentage of region of interest in UWFA Standard Deviation 0.12

SECONDARY outcome

Timeframe: 6 months

Change in panretinal ischemic index (defined as the proportion of retinal area with nonperfusion) from baseline at 6 months

Outcome measures

Measure	Aflibercept n=28 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Change in Panretinal Ischemic Index From Baseline at 6 Months	0.67 percentage of region of interest in UWFA Standard Deviation 0.03

SECONDARY outcome

Timeframe: 6 months

OCT central subfield thickness change from baseline to 6 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Mean Change From Baseline Central Subfield Thickness	278.0 μm Standard Deviation 251.3

SECONDARY outcome

Timeframe: 12 months

Mean change from baseline in best-corrected visual acuity (BCVA) score from baseline to month 12

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS	18.4 ETDRS letters Standard Deviation 21.4

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Participants Who Gained 15 ETDRS Letters or More of Vision	13 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Patients Who Gained 15 ETDRS Letters or More of Vision	12 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Patients That Showed Visual Acuity 20/40 or Better	20 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Patients That Showed Visual Acuity 20/200 or Worse	2 Participants

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled subjects

Outcome measures

Measure	Aflibercept n=31 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Ocular Serious Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Participants Who Lost 15 ETDRS Letters or More of Vision	1 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Participants Who Lost 15 ETDRS Letters or More of Vision	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Patients That Showed Visual Acuity 20/40 or Better	19 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Number of Patients That Showed Visual Acuity 20/200 or Worse	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Aflibercept n=29 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Mean Change From Baseline Central Subfield Thickness	301.3 μm Standard Deviation 250.3

SECONDARY outcome

Timeframe: 12 Months

Population: All subjects enrolled

Incidence of systemic SAEs

Outcome measures

Measure	Aflibercept n=31 Participants Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Systemic Serious Adverse Events	3 Participants

Adverse Events

Aflibercept

Serious events: 3 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Aflibercept n=31 participants at risk Monthly aflibercept for 6 months and then every other month for 6 months. Aflibercept: Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
General disorders Death	6.5% 2/31 • 1 year
Nervous system disorders Stroke	3.2% 1/31 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr.Justis P. Ehlers

Cole Eye Institute Cleveland Clinic Foundation

Phone: 2166360183

Email: ehlersj@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place