Analysis of Aqueous and Vitreous Humor (ARK)

February 28, 2017 updated by: Robert Avery, California Retina Consultants

Analysis of Vitreous and Aqueous Humor for Ocular Growth Factors, Cytokines, Chemokines, and Ranibizumab Pharmacokinetics Associated With Various Retinal Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, pilot study of intravitreally administered ranibizumab in subjects undergoing pars plana vitrectomy (PPV) to repair tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative serous retinal detachment, macular hole or neovascular glaucoma.

Consented, enrolled subjects will be eligible to receive a single open-label intravitreal injection of 0.5 mg ranibizumab administered prior to undergoing PPV if in the Retinal Specialists opinion there could be a benefit to the disease or procedure from ranibizumab therapy.

The proposed study will analyze aqueous humor and vitreous samples drawn at the same time during vitrectomy to evaluate the levels of growth factors, cytokines and chemokines from patients undergoing planned pars plana vitrectomy as part of their retinal care. For patients receiving ranibizumab, serum samples will also be collected to assess PK. Patients will be split into three groups based on diagnosis: Group 1: (ranibizumab) proliferative diabetic retinopathy (tractional retinal detachment), macular degeneration with exudative or tractional retinal detachment, macular hole or neovascular glaucoma. Group 1 may receive one injection of intravitreal ranibizumab 0.5mg prior to vitrectomy. The injection will be administered at least 1-14 days prior to vitrectomy. Group 2 will serve as the control group and will not receive intravitreal ranibizumab prior to surgery.

Aqueous humor, vitreous and serum samples will be obtained to measure and compare growth factor, cytokine, chemokine levels and ranibizumab levels (if received). Undiluted core vitreous biopsies will be taken at the start of victrectomy. Aproximately 1 mL of undiluted vitreous fluid will be obtained with a closed infusion line and by manual aspiration with cutting on through the vitrectomy probe into a 2.5 mL syringe connected along the aspiration line. The sample will be frozen immediately and stored at -80°C.

Approximately 100 microliters of aqueous humor will be collected prior to the start of vitrectomy through anterior chamber paracentesis in the peripheral clear cornea using a 27 gauge needle on a tuberculin microsyringe from the central papillary area. Aqueous is transferred to a vial and placed in liquid nitrogen upon removal from the anterior chamber. Aqueous humor samples are immediately frozen at -80°C within 2 hours of collection until transferred to outside laboratories for further analysis.

Serum samples will be obtained from patients in Group 1 at baseline (Day 0) prior to treatment with intravitreal ranibizumab and on the day of surgery prior to the start of vitrectomy. Serum samples will be processed according to Genentech standard operating procedures and samples will be frozen immediately at -80C until analysis is ready to begin.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93103
        • Recruiting
        • California Retina Consultants - Santa Barbara Office
        • Contact:
        • Principal Investigator:
          • Robert L Avery, MD
        • Sub-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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Ranibizumab
Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.
Other Names:
  • Lucentis
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).
Other: No Ranibizumab
Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine Levels
Time Frame: Collected at Baseline
Growth factor, cytokine, chemokine , and ranibizumab (if applicable) concentration in aqueous and vitreous samples collected during pars plana vitrectomy
Collected at Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Pharmacokinetics
Time Frame: Up to Day 14
Serum pharmacokinetic levels following a single intravitreal ranibizumab injection.
Up to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Retina Consultants

Investigators

  • Principal Investigator: Robert L Avery, MD, California Retina Consultants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28894s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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