Trial Outcomes & Findings for Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study (NCT NCT01077401)

NCT ID: NCT01077401

Last Updated: 2017-04-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 152 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2017-04-28

Participant Flow

Participant milestones

Measure	Ranibizumab 0.5mg Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Overall Study STARTED	77	75
Overall Study COMPLETED	59	54
Overall Study NOT COMPLETED	18	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study

Baseline characteristics by cohort

Measure	Ranibizumab 0.5mg n=77 Participants Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg n=75 Participants Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.	Total n=152 Participants Total of all reporting groups
Age, Continuous	64.8 years n=5 Participants	63.5 years n=7 Participants	64.1 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	37 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	38 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	39 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	75 participants n=7 Participants	152 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Measure	Ranibizumab 0.5mg n=77 Participants Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg n=75 Participants Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Deaths Due to Myocardial Infarction	1 participants	3 participants

SECONDARY outcome

Timeframe: baseline 6 Months

Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.

Outcome measures

Measure	Ranibizumab 0.5mg n=77 Participants Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg n=75 Participants Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Mean Change in Best Corrected Visual Acuity From Baseline to Month 6	9.34 letters Standard Deviation 10.34	7.04 letters Standard Deviation 8.33

SECONDARY outcome

Timeframe: baseline to6 Months

Population: Data was not collected for 4 participants in the Ranibizumab 0.5mg group for this outcome measure.

Outcome measures

Measure	Ranibizumab 0.5mg n=73 Participants Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg n=75 Participants Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Mean Change in Retinal Thickness at Month 6	168.57 µm Standard Deviation 145.67	159.69 µm Standard Deviation 124.50

Adverse Events

Ranibizumab 0.5mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Ranibizumab 2.0 mg

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ranibizumab 0.5mg n=77 participants at risk Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg n=75 participants at risk Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Cardiac disorders Deaths from Myocardial Infarction within 6 months of starting study	1.3% 1/77 • Number of events 1 • 6 months	4.0% 3/75 • Number of events 3 • 6 months

Other adverse events

Measure	Ranibizumab 0.5mg n=77 participants at risk Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.	Ranibizumab 2.0 mg n=75 participants at risk Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Eye disorders Loss of 30 or more letters	1.3% 1/77 • Number of events 1 • 6 months	0.00% 0/75 • 6 months

Additional Information

Quan Dong Nguyen, MD, MSc

University of Nebraska

Phone: 4025591855

Email: quan.nguyen@unmc.edu

Results disclosure agreements

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