Trial Outcomes & Findings for The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study (NCT NCT00407381)

NCT ID: NCT00407381

Last Updated: 2017-03-31

Results Overview

Mean change of best corrected visual acuity letters (BCVA) at month 6

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 126 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-03-31

Participant Flow

Participant milestones

Measure	Ranibizumab Only Ranibizumab (RBZ) intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.	Laser Only Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.	Laser With Ranibizumab (RBZ) Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Overall Study STARTED	42	42	42
Overall Study COMPLETED	39	38	40
Overall Study NOT COMPLETED	3	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

Baseline characteristics by cohort

Measure	Ranibizumab Only n=42 Participants RBZ intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.	Laser Only n=42 Participants Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.	Laser With RBZ n=42 Participants Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.	Total n=126 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	74 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	52 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Mean change in BCVA at month 6

Mean change of best corrected visual acuity letters (BCVA) at month 6

Outcome measures

Measure	RBZ Alone n=42 Participants RBZ intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.	Laser Alone n=42 Participants Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.	Laser With RBZ n=42 Participants Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6	7.24 Mean letter change in BCVA Standard Deviation 5.54	-0.43 Mean letter change in BCVA Standard Deviation 4.56	3.8 Mean letter change in BCVA Standard Deviation 5.2

Adverse Events

Ranibizumab Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Laser Only

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Laser With Ranibizumab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ranibizumab Only n=42 participants at risk RBZ intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.	Laser Only n=42 participants at risk Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.	Laser With Ranibizumab n=42 participants at risk Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Vascular disorders Cerebrovascular Event	0.00% 0/42 • 6 Months	0.00% 0/42 • 6 Months	2.4% 1/42 • Number of events 1 • 6 Months

Other adverse events

Measure	Ranibizumab Only n=42 participants at risk RBZ intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.	Laser Only n=42 participants at risk Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.	Laser With Ranibizumab n=42 participants at risk Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Eye disorders Vitreous Hemorrhages	2.4% 1/42 • Number of events 1 • 6 Months	9.5% 4/42 • Number of events 4 • 6 Months	7.1% 3/42 • Number of events 3 • 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