Phase 4 N=10 Basic Science

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

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT03097068 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Vascular Endothelial Growth Factor Levels — 73.46 pg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lucentis (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vitreo-Retinal Associates, Michigan
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Vascular Endothelial Growth Factor Levels	73.46	—

Summary

The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Eligibility Criteria

Inclusion Criteria

Diagnosis of diabetes mellitus
Best corrected visual acuity 20/32 - 20/320
Diabetic macular edema involving the center of the macula
Optical coherence tomography central subfield thickness of at least 250 microns

Exclusion Criteria

History of anti-vascular endothelial growth factor treatment in the past 12 months
Any diabetic macular edema treatment in the past 4 months
Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03097068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.