Clinical trial NCT02806752: Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy
Official title: Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Wet Macular Degeneration
Keywords: Polypoidal Choroidal Vasculopathy
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of mean BCVA
timeFrame: 12 months
Secondary outcomes:
measure: Change of Central Rerina Thickness
timeFrame: 12 months
measure: regression of Branch vacular network(BVN)
timeFrame: 12 months
measure: Polyps regression
timeFrame: 12 months
measure: Number of re-treatments
timeFrame: 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Aier Intech Eye Hospital
state: Beijing
city: Guanzhou
country: China
facility: Guangzhou Aier Eye Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Aier Eye Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Aier Eye Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan General Hospital of PLA
state: Hubei
city: Wenzhou
country: China
facility: The Eye Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Aier School of Ophthalmology, Central South University
name: Shibo Tang
role: STUDY_CHAIR
References: