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

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.