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

Xiaodong Sun

Status and phase: Unknown; Phase 4

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Procedure: OCTA plus OCT guided 3+PRN regimen; Procedure: OCT guided 3+PRN regimen; Drug: Anti-VEGF drug

Study type: Interventional

Funder types: Other

Identifiers

NCT04380974

PCV20200506

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

OCTA plus OCT guided 3+PRN regimen

Experimental group

Description:

Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization, OCTA and OCT in the extension treatment period.

Treatment:

Drug: Anti-VEGF drug

Procedure: OCTA plus OCT guided 3+PRN regimen

OCT guided 3+PRN regimen

Active Comparator group

Description:

Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization and OCT in the extension treatment period.

Treatment:

Drug: Anti-VEGF drug

Procedure: OCT guided 3+PRN regimen