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

Phase 4

• Conditions: Polypoidal Choroidal Vasculopathy
• Interventions: Procedure: OCTA plus OCT guided 3+PRN regimen; Procedure: OCT guided 3+PRN regimen; Drug: Anti-VEGF drug

• Registration Number: NCT04380974
• Lead Sponsor: Xiaodong Sun

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-08
• Last Update Posted: 2020-05-08
• Study Start: 2020-06
• Primary Completion: 2020-10
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCTA plus OCT guided 3+PRN regimen	OCTA plus OCT guided 3+PRN regimen	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.
OCTA plus OCT guided 3+PRN regimen	Anti-VEGF drug	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.
OCT guided 3+PRN regimen	OCT guided 3+PRN regimen	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.
OCT guided 3+PRN regimen	Anti-VEGF drug	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.

Primary Outcome Measures

Name	Time	Method
PCV lesion recurrence	24 months	PCV lesion recurrence is defined as the reappearance of new exudative biomakers (such as IRF, SRF, PED) or new hemorrhage detected on OCT or fundus examination in subsequent visits from the last visit showing clinical stability. PCV lesion recurrence rate will be compared at 24months between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.

Secondary Outcome Measures

Name	Time	Method
Mean central macular thickness at every visit or treatment by OCT	24 months	Compare of mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
Mean Snellen BCVA at every visit or treatment	24 months	Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
Number of participants with treatment-related adverse events	24 months	Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of OCTA plus OCT guided 3+PRN regimen
Mean number of injections after the initial three loading dose monthly injections	21 months	Compare of mean number of injections after the initial three loading dose monthly injections between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China