Overview

Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy

Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
Summary
The study will evaluate the efficacy and safety of two different regimens of anti-VEGF Therapy (OCTA plus OCT guided 3+PRN vs. OCT guided 3+PRN) in Chinese patients with PCV. This study is to provide long-term safety data in the treatment of Chinese patients with PCV.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xiaodong Sun
Collaborators:
Eye & ENT Hospital of Fudan University
Shanghai Zhongshan Hospital
Treatments:
Bevacizumab
Criteria
Inclusion Criteria:

- Written informed-consent before any evaluation

- Visual impairment due to PCV, including type 1 PCV and type 2 PCV.

- 50 years old and older

- Chinese

- For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at
the time point of both screening and baseline.

Exclusion Criteria:

- Have Stroke and myocardial infarction within 3 months before screening

- Any active periocular and ocular infection and inflammation (including blepharitis,
conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while
screening and baseline.

- Uncontrolled glaucoma (under treatment [IOP] ≥ 30 mm Hg or depend on researchers)
while screening and baseline

- Neovascularization of iris and neovascular glaucoma while screening and baseline

- Any causes led to choroidal neovascularization except PCV (including ICNV, central
serous chorioretinopathy, ocular histoplazmoza and pathologic myopia) while screening
and baseline

- With structure injury (including vitreous macular traction,epiretinal membrane
involving in central fovea,subretinal fibroplasia,laser scar and central fovea
atrophy) within 0.5 optic disc diameter to the central of macula while screening and
baseline, which may harm the improvement of vision by treatment according to
researchers

- Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening

- Any medication systemic use toxic to lens, retina and optic nerve, including iron
amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol

- For study eye: Used to accept following treatments for PCV within 3 months or accept
following treatments more than three times before baseline:

1. Anti-angiogenesis drugs (pegaptanib, ranibizumab, bevacizumab),VEGF-Trap;

2. Anecortave acetate corticosteroids;

3. Protein kinase C inhibitors, squalamine, siRNA;

4. PDT, Visudyne® treatment, external beam radiotherapy, local laser
photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy

- Any intraocular surgery (including YAG laser) within 3 months before baseline or
predicated within 6 months after baseline

- Intraocular or periocular treatment of corticosteroids within 3 months before baseline

- For follow eye: Any anti-angiogenesis treatment (including anti-VEGF, like Lucentis,
Avastin and KH902 ) within 3 months before baseline