Macular Degeneration Clinical Trial
Official 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.
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.
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