Intraocular injection conbercept is effective to improve vision, relieve symptoms for patients suffered from polypoidal choroidal vasculopathy
- Conditions
- Treatment-naive PCV characterized by the presence of polyps with or without BVN in posterior pole on indocyanine green angiogram (ICGA), with subretinal/intraretinal fluids observed on optical coherence tomography (OCT) or leakage on fluorescein angiography (FA)Eye DiseasesNaive polypoidal choroidal vasculopathy
- Registration Number
- ISRCTN10396126
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 45
1. Treatment-naive PCV characterized by the presence of polyps with or without BVN in posterior pole on ICGA, with subretinal/intraretinal fluids observed on optical coherence tomography (OCT) or leakage on fluorescein angiography (FA)
2. Received three continuous monthly intravitreal injections of 0.5 mg conbercept followed by as-needed injections
3. Pro re nata (PRN). Reinjection was considered if any intraretinal or subretinal fluid was observed after the third injection.
4. Underwent intravitreal conbercept injections as the primary treatment for PCV and completed at least six months of monthly follow-up exams after the first treatment
5. Aged 50 and older
1. Angioid streaks, multifocal choroiditis, punctate inner choroidopathy, pathologic myopia, retinal angiomatous proliferation or other diseases that can cause choroid neovascularization
2. The presence of any other ocular diseases that might affect visual acuity
3. Received any other treatment, including thermal laser photocoagulation, submacular surgery, intravitreal any other anti-VEGF drugs, and photodynamic therapy (PDT)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Visual outcomes (best-corrected visual acuity BCVA) are measured using an eye test at baseline, and month one, two, three, four, five and six<br>2. Optical coherence tomography (OCT) outcomes CRT are measured manually using a scale of Heidelberg software at baseline and month one, two, three, four, five and six follow-up based on patients’ OCT images, subretinal or intraretinal fluid build-up are evaluated based on OCT at first and the 6-month visit. <br>3. The regression of polyps or BVN, greatest linear dimension (GLD), total lesion area (TLA), polyp largest diameter (PLD), and polyp lesion area (PLA) were assessed based on ICGA at baseline and the visit after three continuous injections. <br>4. Number of treatments is measured using patient interviews at month one, two, three, four, five and six <br>5. Adverse events are measured using patient interviews at month one, two, three, four, five and six monthly follow-up visit <br>
- Secondary Outcome Measures
Name Time Method Polyps (whether they have breached retinal pigment epithelium (RPE)) are measured using OCT images at month one, two, three, four, five and six