Macular Degeneration Clinical Trial
— ARKOfficial title:
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | California Retina Consultants - Santa Barbara Office | Santa Barbara | California |
Lead Sponsor | Collaborator |
---|---|
California Retina Consultants |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Serum Pharmacokinetics | Serum pharmacokinetic levels following a single intravitreal ranibizumab injection. | Up to Day 14 |
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