search
Back to results

Analysis of Aqueous and Vitreous Humor (ARK)

Primary Purpose

Proliferative Diabetic Retinopathy, Macular Degeneration, Macular Hole

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
No Ranibizumab
Sponsored by
California Retina Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Proliferative Diabetic Retinopathy focused on measuring Tractional retinal detachment, Exudative retinal detachment, Macular hole, Neovascular glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Retina Consultants - Santa Barbara OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranibizumab

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum Pharmacokinetics
Serum pharmacokinetic levels following a single intravitreal ranibizumab injection.

Full Information

First Posted
February 17, 2014
Last Updated
February 28, 2017
Sponsor
California Retina Consultants
search

1. Study Identification

Unique Protocol Identification Number
NCT02067013
Brief Title
Analysis of Aqueous and Vitreous Humor
Acronym
ARK
Official Title
Analysis of Vitreous and Aqueous Humor for Ocular Growth Factors, Cytokines, Chemokines, and Ranibizumab Pharmacokinetics Associated With Various Retinal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Retina Consultants

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Macular Degeneration, Macular Hole, Neovascular Glaucoma
Keywords
Tractional retinal detachment, Exudative retinal detachment, Macular hole, Neovascular glaucoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.
Intervention Type
Other
Intervention Name(s)
No Ranibizumab
Intervention Description
Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.
Primary Outcome Measure Information:
Title
Cytokine Levels
Description
Growth factor, cytokine, chemokine , and ranibizumab (if applicable) concentration in aqueous and vitreous samples collected during pars plana vitrectomy
Time Frame
Collected at Baseline
Secondary Outcome Measure Information:
Title
Serum Pharmacokinetics
Description
Serum pharmacokinetic levels following a single intravitreal ranibizumab injection.
Time Frame
Up to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Gordon, PhD
Phone
805-963-1648
Ext
3034
Email
gabe@californiaretina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Avery, MD
Organizational Affiliation
California Retina Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Retina Consultants - Santa Barbara Office
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Gordon, PhD
Phone
805-963-1648
Ext
3034
Email
gabe@californiaretina.com
First Name & Middle Initial & Last Name & Degree
Robert L Avery, MD
First Name & Middle Initial & Last Name & Degree
Ma'an A Nasir, MD
First Name & Middle Initial & Last Name & Degree
Dante J Pieramici, MD
First Name & Middle Initial & Last Name & Degree
Alessandro A Castellarin, MD
First Name & Middle Initial & Last Name & Degree
Robert F See, MD
First Name & Middle Initial & Last Name & Degree
Stephen S Couvillion, MD
First Name & Middle Initial & Last Name & Degree
Nathan C Steinle, MD
First Name & Middle Initial & Last Name & Degree
Dilsher S Dhoot, MD

12. IPD Sharing Statement

Learn more about this trial

Analysis of Aqueous and Vitreous Humor

We'll reach out to this number within 24 hrs