Initial Versus Delayed PDT Combination With Conbercept in PCV

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Eye Hospital of Wenzhou Medical University
• Treatments: Verteporfin

Criteria

Inclusion Criteria:

1. Either gender，age ≥ 40.

2. BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).

3. Naive symptomatic PCV patients.

4. Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.

5. No refractive media opacity or small pupil narrow that influence the fundus examination.

6. Women must be using effective contraception, be post-menopausal for at least months prior to trial entry, or surgically sterile.

7. Ability to provide written informed consent and to return for all study visits.

Exclusion Criteria:

1. Active inflammation or infection in the study eye.

2. Uncontrolled intraocular pressure (>25 mmHg) in the study eye.

3. Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epiretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).

4. Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.

5. Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.

6. Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.

7. Allergy to fluorescein, ICG, iodine, shellfish.

8. Pregnant or breast-feeding women.