Analysis of Aqueous and Vitreous Humor

Part of paid clinical trials in Santa Barbara, California.

Sponsor
California Retina Consultants
Study ID
NCT02067013
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.
  • No Ranibizumab — OTHER
    Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.

Study Details

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.

Key Dates

First listed
Feb 20, 2014
Start date
Jul 31, 2015
Status verified
Feb 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Ranibizumab
    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.
  • Placebo Comparator: Control
    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).

Primary Outcome Measure

Cytokine Levels [ Time Frame: Collected at Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
California Retina Consultants - Santa Barbara OfficeSanta BarbaraCalifornia93103
Gabriel Gordon, PhD
[email protected]
805-963-1648
Robert L Avery, MD (PRINCIPAL_INVESTIGATOR)
Ma'an A Nasir, MD (SUB_INVESTIGATOR)
Dante J Pieramici, MD (SUB_INVESTIGATOR)
Alessandro A Castellarin, MD (SUB_INVESTIGATOR)
Robert F See, MD (SUB_INVESTIGATOR)
Stephen S Couvillion, MD (SUB_INVESTIGATOR)
Nathan C Steinle, MD (SUB_INVESTIGATOR)
Dilsher S Dhoot, MD (SUB_INVESTIGATOR)

Find similar trials in Santa Barbara, CA

By condition
Age-related macular degenerationDiabetic retinopathy
By specialty
OphthalmologyRetina
By research site
California Retina Consultants - Santa Barbara Office· Santa Barbara, CA

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