Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/6/2019
Start Date:January 2015
End Date:July 2021
Contact:Gulnar Hafiz, MD, MPH
Email:ghafiz1@jhmi.edu

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This study will examine potential factors in the aqueous humor that may contribute to the
development or progression of macular edema or fibrosis (due to any underlying disease) in
patients suffering from these conditions.

The primary purpose of this study is to determine the correlation of pro-permeability and
pro-fibrosis factor levels and downstream receptor/signaling molecule activation with disease
activity in patients with macular edema or fibrosis secondary to any underlying disease.

120 patients will be enrolled from both the clinic and OR, with the latter patients
undergoing surgery for proliferative diabetic retinopathy, rhegmatogenous retinal detachment
with Proliferative vitreoretinopathy (PVR), rhegmatogenous retinal detachment without PVR,
macular pucker, or macular hole. Clinic patients must be receiving an intraocular injection
of a steroid as part of standard of care for macular edema or progressive fibrosis.

Surgical patients will receive an anterior chamber (AC) tap at the beginning of surgery,
while clinic patients will receive an AC tap prior to the intraocular injection of steroid
with a second AC tap at a follow-up visit 6 +/- 2 weeks after the first injection. The
aqueous sample will then be analyzed by measuring the levels of various pro-permeability and
pro-fibrosis factors and/or their downstream receptor/signaling molecule activation.

We will also determine the correlation between reductions in foveal thickness or improvements
in visual acuity with changes in the aqueous levels of pro-permeability and pro-fibrosis
factors from baseline to week 6 in the clinic group.

Inclusion Criteria:

- Signed informed consent and authorization of use and disclosure of protected health
information

- Age >= 18 years

- Undergoing surgery as part of standard care for one of the following conditions: (1)
Proliferative Diabetic Retinopathy (PDR), (2) rhegmatogenous retinal detachment with
PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5)
macular hole OR receiving as part of standard care, an intraocular injection of a
steroid for macular edema or progressive fibrosis.

Exclusion Criteria:

- Previous use of an anti-Vascular Endothelial Growth Factor (VEGF) drug within 1 month
of study entry

- Any condition that the investigator believes would pose a significant hazard to the
subject if standard study procedures were conducted.

- Inability to comply with study or follow up procedures

- Patients with active or suspected ocular or periocular infection, including most viral
diseases of the cornea and conjunctiva, including active epithelial herpes simplex
keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and
fungal diseases.

- Pregnant patients.
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