Trial Outcomes & Findings for Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (NCT NCT01402544)

Last Updated: 2019-08-28

Results Overview

PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

Baseline, Month 6 and Month 12

Results posted on

2019-08-28

Participant Flow

The Principal Investigator is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from 'UCSD' site. Data from these participants is being reported here.

Participant milestones

Participant milestones
Measure	Ranibizumab 0.5 mg Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Overall Study STARTED	12
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranibizumab 0.5 mg Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Overall Study Withdrawal by Subject	6

Baseline Characteristics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab 0.5 mg n=12 Participants Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Age, Continuous	84.42 years STANDARD_DEVIATION 6.86 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants • PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here

PRIMARY outcome

Timeframe: Baseline, Month 6 and Month 12

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg n=6 Participants Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months	3 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg n=6 Participants Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. Change from Baseline to Month 6	-3.333 letters Standard Deviation 4.082
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months. Change from Baseline to Month 12	-9.167 letters Standard Deviation 9.174

SECONDARY outcome

Timeframe: Baseline, Month 6 and Month 12

Population: PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.The CFT image for one participant could not be located, so only 5 of the 6 enrolled participants data are being reported.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg n=5 Participants Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months Change from Baseline to Month 6	-23.4 microns Standard Deviation 25.126
Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months Change from Baseline to Month 12	-25.2 microns Standard Deviation 21.029

Adverse Events

Ranibizumab 0.5 mg

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ranibizumab 0.5 mg n=20 participants at risk；n=12 participants at risk Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year ranibizumab: 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
Cardiac disorders Non-ST segment elevation myocardial infarction	8.3% 1/12 • Number of events 1 PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here
Eye disorders Decrease/Blurry Vision	8.3% 1/12 • Number of events 1 PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here
Eye disorders Eye Pain	33.3% 4/12 • Number of events 4 PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here

Other adverse events

Adverse event data not reported

Additional Information

Dr. Henry Ferreyra

Univeristy of California, San Diego

Phone: 858-822-7982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place