NCT03097068

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

October 24, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

March 21, 2017

Results QC Date

May 4, 2022

Last Update Submit

October 21, 2022

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Vascular Endothelial Growth Factor Levels

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

    12 weeks

Study Arms (1)

0.3 mg Lucentis

EXPERIMENTAL

Aqueous Humor sample post injection of 0.3 mg Lucentis

Drug: Lucentis

Interventions

LucentisDRUG

0.3mg Lucentis

Also known as: Aqueous Tap
0.3 mg Lucentis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49546, United States

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Louis C. Glazer, MD
Organization
Vitreo-Retinal Associates, P.C.
glazerlc@vrapc.com
1-616-285-1200

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 31, 2017

Study Start

April 19, 2017

Primary Completion

December 6, 2017

Study Completion

February 2, 2018

Last Updated

October 24, 2022

Results First Posted

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)