Trial Outcomes & Findings for Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis (NCT NCT03097068)

Last Updated: 2022-10-24

Results Overview

An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-10-24

Participant milestones
Measure	0.3 mg Lucentis Aqueous Humor sample post injection of 0.3 mg Lucentis Lucentis: 0.3mg Lucentis
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

Baseline characteristics by cohort
Measure	0.3 mg Lucentis n=10 Participants Aqueous Humor sample post injection of 0.3 mg Lucentis Lucentis: 0.3mg Lucentis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 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	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
OCT Central Subfield Thickness	518.1 microns STANDARD_DEVIATION 257.19 • n=5 Participants

Timeframe: 12 weeks

An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.

Outcome measures
Measure	0.3 mg Lucentis n=10 Participants Aqueous Humor sample post injection of 0.3 mg Lucentis Lucentis: 0.3mg Lucentis
Vascular Endothelial Growth Factor Levels	73.46 pg/ml Interval 40.06 to 112.3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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