Polypoidal Choroidal Vasculopathy, PCV. Typical symptoms include decreased visual acuity, metamorphopsia, central scotoma, etc.
Conditions
Interventions
Brolucizumab treatment group:Brolucizumab 6mg intravitreal injection
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 50 years or older (inclusive); 2. Diagnosed with polypoidal choroidal vasculopathy (PCV) within the past 6 months; 3. No prior history of intravitreal anti-VEGF therapy; 4. Best-corrected visual acuity (BCVA) score of 24 to 78 letters (inclusive) as measured by the ETDRS chart (approximately equivalent to a Snellen visual acuity fraction of 20/320 to 20/20, inclusive); 5. Active polypoidal lesions in the macular area as evidenced by indocyanine green angiography (ICGA), with serous or hemorrhagic features detected by color fundus photography, fluorescein angiography, or SS-OCT, along with the presence of intraretinal fluid or subretinal fluid affecting the foveal center on SS-OCT. 6. Adequate patient cooperation for color fundus photography, fluorescein angiography, and SS-OCT imaging, with sufficient pupil dilation and clear ocular media in the study eye to permit high-quality fundus examination. 7. Voluntarily participation in the study, demonstrated by providing written informed consent, and willingness to comply with all required follow-up visits.
Exclusion criteria
Exclusion criteria: 1. At screening or baseline, the presence of any concomitant ocular condition or disease in the study eye which might prevent a response to treatment, confound the interpretation of study results, compromise vision, or require medical or surgical intervention within the first 7 months of the study (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization from any cause, or glaucoma). 2. At screening or baseline, any active intraocular or periocular infection or active non-infectious intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis), or a history of intraocular inflammation. 3. At screening or baseline, uncontrolled glaucoma in the study eye, defined as intraocular pressure (IOP) > 25 mmHg despite medical therapy, or as judged by the investigator. 4. Other diseases with manifestations similar to PCV, such as retinal arterial macroaneurysms or telangiectasia, should be excluded. 5. Subretinal hemorrhage in the study eye exceeding an area of 9 optic disc areas or involving = 50% of the total lesion area, or the presence of vitreous hemorrhage. 6. Previous treatment with intravitreal anti-VEGF injections in the study eye. 7. Previous treatment with an intravitreal fluocinolone acetonide implant (Iluvien) in the study eye. Study eyes that have received other intraocular or periocular corticosteroid therapy are only excluded if administered within a washout period of less than 6 months prior to baseline. 8. Macular laser photocoagulation (focal/grid) at any time prior to baseline, or peripheral laser photocoagulation within 3 months prior to baseline. 9. Any previous systemic anti-VEGF therapy at any time prior to baseline. 10. History of stroke or myocardial infarction within 6 months prior to baseline. 11. Poorly controlled hypertension, defined as systolic blood pressure = 180 mmHg or diastolic blood pressure = 100 mmHg. 12. Serum creatinine level > 200 µmol/L, a history of end-stage renal disease (requiring dialysis or renal transplantation), or a prior renal transplant. 13. History of hypersensitivity to contrast agents or severe drug allergies. 14. Pregnancy. 15. Any other condition deemed by the investigator as a reason for exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polyp regression rate (complete regression); | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Best Corrected Visual Acuity (BCVA);The macular structure showed by SS-OCT;Changes in imaging indicators of OCT and SS-OCTA (e.g., blood flow density, polyp diameter, polyp area, neovascular network area, etc.);Safety Evaluation Indicators;Changes in the number of polyp lesions and choroidal vascular permeability; | — |
Countries
China
Contacts
Public ContactYouxin Chen
Peking Union Medical College Hospital
Outcome results
None listed