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

• Status: Terminated
• Trial end date: 2021-10-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University; Peter A Campochiaro, MD
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.