Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy

NCT ID: NCT02806752

Last Updated: 2018-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Wet Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ranibizumab + Triamcinolone Acetonide

intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg

Group Type: EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type: DRUG

Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.

Ranibizumab

Intervention Type: DRUG

Intravitreal inject 0.5mg of Ranibizumab.

Ranibizumab

intravitreal injection: Ranibizumab 0.5mg

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Intravitreal inject 0.5mg of Ranibizumab.

Interventions

Triamcinolone Acetonide

Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.

Intervention Type: DRUG

Ranibizumab

Intravitreal inject 0.5mg of Ranibizumab.

Intervention Type: DRUG

Other Intervention Names

RANTA; RAN

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shibo Tang

Role: STUDY_CHAIR

Aier School of Ophthalmology, Central South University

Locations

Beijing Aier Intech Eye Hospital

Beijing, Beijing Municipality, 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

Countries

China

Other Identifiers

IRB2016006

Identifier Type: -

Identifier Source: org_study_id