NCT02067013

Brief Summary

Clinical Retina research studies often collect aqueous samples in hopes of estimating levels of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous correlate. This study will collect vitreous and aqueous samples at the same time to evaluate and compare drug and cytokine levels. The overall objective of this study is to evaluate the molecular concentration of growth factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to macular degeneration, macular hole or neovascular glaucoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

February 17, 2014

Last Update Submit

February 28, 2017

Conditions

Proliferative Diabetic RetinopathyMacular DegenerationMacular HoleNeovascular Glaucoma

Keywords

Tractional retinal detachmentExudative retinal detachmentMacular holeNeovascular glaucoma

Outcome Measures

Primary Outcomes (1)

  • Cytokine Levels

    Growth factor, cytokine, chemokine , and ranibizumab (if applicable) concentration in aqueous and vitreous samples collected during pars plana vitrectomy

    Collected at Baseline

Secondary Outcomes (1)

  • Serum Pharmacokinetics

    Up to Day 14

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

Subjects undergoing surgery for neovascular glaucoma, diabetic retinopathy, or tractional Retinal Detachment due to AMD will receive one intravitreal injection of ranibizumab within 2 weeks of their surgery. Vitreous and aqueous humor samples will be collected during the surgery. Serum samples may be collected before, during, or after surgery.

Drug: Ranibizumab

Control

PLACEBO COMPARATOR

Subjects undergoing surgery for ERM or macular hole will NOT receive an injection of ranibizumab, but will have vitreous, and aqueous humor samples collected during surgery (no serum collection).

Other: No Ranibizumab

Interventions

No RanibizumabOTHER

Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.

Control
RanibizumabDRUG

Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.

Also known as: Lucentis
Ranibizumab

Eligibility Criteria

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

You may qualify if:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age \> 18 years
  • Subjects with a diagnosis of tractional retinal detachment secondary to proliferative diabetic retinopathy, age-related macular degeneration with tractional or exudative retinal detachment, macular hole, epiretinal membrane, or neovascular glaucoma.

You may not qualify if:

  • Subjects with history of vitrectomy in the study eye
  • Presence of vitreous hemorrhage
  • Subjects with history of laser photocoagulation in the study eye within 3 months of vitrectomy
  • Subjects unwilling to undergo pars plana vitrectomy
  • Subjects unwilling to receive intravitreal ranibizumab prior to pars plana vitrectomy unless diagnosis of macular hole or epiretinal membrane
  • Subjects who may need or have received systemic anti-VEGF for oncology in the past year
  • Subjects with history of anti-VEGF injection within 4 months before vitrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Retina Consultants - Santa Barbara Office

Santa Barbara, California, 93103, United States

RECRUITING

MeSH Terms

Conditions

Macular DegenerationRetinal PerforationsGlaucoma, Neovascular

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesGlaucomaOcular Hypertension

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Robert L Avery, MD

    California Retina Consultants

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Gordon, PhD

CONTACT

805-963-1648gabe@californiaretina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
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

February 17, 2014

First Posted

February 20, 2014

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

US(1)