Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 120
- Locations
- 7
- Primary Endpoint
- Change of mean BCVA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
Exclusion Criteria
- •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)
Arms & Interventions
Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
Intervention: Triamcinolone Acetonide (Drug)
Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
Intervention: Ranibizumab (Drug)
Ranibizumab
intravitreal injection: Ranibizumab 0.5mg
Intervention: Ranibizumab (Drug)
Outcomes
Primary Outcomes
Change of mean BCVA
Time Frame: 12 months
Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
Secondary Outcomes
- Change of Central Rerina Thickness(12 months)
- Polyps regression(12 months)
- regression of Branch vacular network(BVN)(12 months)
- Number of re-treatments(12 month)