Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy
- Conditions
- Wet Macular Degeneration
- Interventions
- Registration Number
- NCT02806752
- Lead Sponsor
- Aier School of Ophthalmology, Central South University
- Brief Summary
The purpose of this study is to evaluate the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy (PCV). Furthermore, the pharmacogenetics effect of inflammatory related genes polymorphism in response to the treatments. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV.
- Detailed Description
Polypoidal choroidal vasculopathy (PCV), a vascular disease of the choroid, appears to be the predominant subtype of exudative or "wet" AMD in Asian populations, in contrast to choroidal neovascularization secondary to AMD (CNV-AMD) in Western populations. There are distinct differences in pathophysiological, clinical and epidemiological factors between the two subtypes, although they also share some common risk factors. In contrast to CNV-AMD, PCV does not seem to respond as well to anti-VEGF treatment. The optimal treatment option for PCV remains elusive, with most studies showing good short-term visual outcome but poorer longer-term outcome with current treatment strategies. Therefore, understanding the pathogenesis of PCV, while developing novel and effective treatments strategies to prevent PCV-related vision loss is significant unmet needs.
The purpose of this study is to assess the effects and safety of ranibizumab therapy combined with TA versus ranibizumab monotherapy in patients with PCV. Second, the pharmacogenetics effect of inflammatory related genes and polymorphism in response to the treatments of PCV will be explored. To further confirm the role of inflammatory factors in the pathogenesis and advance of PCV, it is important to determine the levels of inflammatory factors in the anterior chamber aqueous humor from PCV patients, comparing with the aqueous humor acquired from the age-matched age-related cataract patients undergoing phacoemulsification.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- bestcorrected visual acuity (BCVA) letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts at a starting distance of 4 m (20/40 to 20/320 Snellen equivalent);
- a greatest lineardimensionof the lesion of <5400 um( 9 Macular Photocoagulation Study disk areas), assessed by ICGA;
- Cross-reading by different center to confirmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyperfluorescence (appearing within the first 6 minutes after injection of indocyanine green) and in addition, at least one of the following angiographic or clinical criteria: (i) association with a BVN, (ii) presence of pulsatile polyp, (iii) nodular appearance when viewed stereoscopically, (iv) presence of hypofluorescent halo (in first 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (defined as size of hemorrhage of at least 4 disk areas).
- received treatment previously with verteporfin PDT, focal laser photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood, or any investigational treatment;
- a history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia;
- experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma;
- undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation within 60 days before the screening visit)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ranibizumab + Triamcinolone Acetonide Ranibizumab intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg Ranibizumab + Triamcinolone Acetonide Triamcinolone Acetonide intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg Ranibizumab Ranibizumab intravitreal injection: Ranibizumab 0.5mg
- Primary Outcome Measures
Name Time Method Change of mean BCVA 12 months Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
- Secondary Outcome Measures
Name Time Method Change of Central Rerina Thickness 12 months Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
Polyps regression 12 months Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
regression of Branch vacular network(BVN) 12 months Size of Branch vascular network (um)
Number of re-treatments 12 month re-treatments numbers
Trial Locations
- Locations (7)
Beijing Aier Intech Eye Hospital
🇨🇳Beijing, Beijing, China
Guangzhou Aier Eye Hospital
🇨🇳Guanzhou, Guangdong, China
Shenzhen Aier Eye Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen Eye Hospital
🇨🇳Shenzhen, Guangdong, China
Harbin Aier Eye Hospital
🇨🇳Harbin, Heilongjiang, China
Wuhan General Hospital of PLA
🇨🇳Wuhan, Hubei, China
The Eye Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Beijing Aier Intech Eye Hospital🇨🇳Beijing, Beijing, China