Trial Outcomes & Findings for Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME (NCT NCT02363621)

NCT ID: NCT02363621

Last Updated: 2019-04-26

Results Overview

Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 101 participants
• Primary outcome timeframe: 24 to 48 hours (visit #1)
• Results posted on: 2019-04-26

Participant Flow

Participant milestones

Measure	Ranibizumab 0.3 Intravitreal Injection Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg	Aflibercept 2.0 mg Intravitreal Injection Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg
Overall Study STARTED	51	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME

Baseline characteristics by cohort

Measure	Ranibizumab 0.3 Intravitreal Injection n=51 Participants Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg	Aflibercept 2.0 mg Intravitreal Injection n=50 Participants Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	44 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants
Diabetic Macular Edema	51 Participants n=5 Participants	50 Participants n=7 Participants	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 to 48 hours (visit #1)

Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam.

Outcome measures

Measure	Ranibizumab 0.3 Intravitreal Injection n=50 Participants Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg	Aflibercept 2.0 mg Intravitreal Injection n=50 Participants Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg
Number of Participants With Intraocular Inflammation	6 Participants	10 Participants

PRIMARY outcome

Timeframe: 5 to 7 days (visit #2)

Population: Inflammation 5 to 7 days after injection

Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam

Outcome measures

Measure	Ranibizumab 0.3 Intravitreal Injection n=50 Participants Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg	Aflibercept 2.0 mg Intravitreal Injection n=50 Participants Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg
Number of Participants With Intraocular Inflammation	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 24 to 48 hours visit #1 and 5 to 7 days visit #2

Pain score rated on a 11 point numerical rating from 0-10 administered to each patient verbally at visit #1 and visit #2.

0 = no pain 10 = severe pain

Outcome measures

Measure	Ranibizumab 0.3 Intravitreal Injection n=50 Participants Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg	Aflibercept 2.0 mg Intravitreal Injection n=50 Participants Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg
Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale. 24 to 48 hours visit #1	28 Participants	28 Participants
Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale. 5 to 7 days visit #2	10 Participants	5 Participants

Adverse Events

Ranibizumab 0.3 Intravitreal Injection

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Aflibercept 2.0 mg Intravitreal Injection

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ranibizumab 0.3 Intravitreal Injection n=51 participants at risk Intravitreal injection of Ranibizumab 0.3 mg once Ranibizumab 0.3 mg: Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg	Aflibercept 2.0 mg Intravitreal Injection n=50 participants at risk Intravitreal Aflibercept 2.0 mg once Aflibercept 2.0 mg: Patient will receive intravitreal injection of Aflibercept 2.0 mg
Eye disorders anterior chamber inflammation	11.8% 6/51 • Number of events 6 • 7 days	20.0% 10/50 • Number of events 10 • 7 days

Additional Information

Dr. Arshad Khanani

Sierra Eye Associates

Phone: 775-329-0286

Email: Arshad.Khanani@gmail.com

Results disclosure agreements

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