Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases (P3F2)

Johns Hopkins University

Status: Terminated

Conditions: Fibrosis of the Retina; Macular Edema

Treatments: Procedure: Surgery; Drug: Ozurdex; Procedure: Anterior Chamber (AC) Tap

Study type: Observational

Funder types: Other

Identifiers

NCT02688309

IRB00045274

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

Clinic Patients

Description:

Patients from the clinic will be considered for enrollment if they are receiving an intraocular injection of a steroid as part of standard care for macular edema or progressive fibrosis. Clinic patients who are receiving an intraocular injection of steroid (Ozurdex) as part of standard care who agree to participate will have an anterior chamber (AC) tap just prior to the intraocular injection of steroid and a second AC tap at a follow up visit 6 ± 2 weeks after the steroid injection.

Treatment:

Procedure: Anterior Chamber (AC) Tap

Drug: Ozurdex

OR Patients

Description:

Patients undergoing surgery for one of the following conditions: (1) Proliferative Diabetic Retinopathy, (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macular hole. Surgical patients who agree to participate will have an anterior chamber (AC) tap at the beginning of surgery.

Treatment:

Procedure: Surgery

Procedure: Anterior Chamber (AC) Tap