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

Wet Macular Degeneration Clinical Trial

— RANTA  

Official title:

Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02806752
• Other study ID #: IRB2016006
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Aier School of Ophthalmology, Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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 con?rmed diagnosis of PCV, that is, presence of early subretinal focal ICGA hyper?uorescence (appearing within the ?rst 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 hypo?uorescent halo (in ?rst 6 minutes),7 (v) orange subretinal nodules in stereoscopic color fundus photograph (polyp corresponding to ICGA lesions), or (vi) association with massive submacular hemorrhage (de?ned as size of hemorrhage of at least 4 disk areas).

Exclusion Criteria:

• received treatment previously with vertepor?n 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)

Related Conditions & MeSH terms

• Macular Degeneration
• Vascular Diseases
• Wet Macular Degeneration

Intervention

Drug:
• Triamcinolone Acetonide
Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
• Ranibizumab
Intravitreal inject 0.5mg of Ranibizumab.

Locations

Country	Name	City	State
China	Beijing Aier Intech Eye Hospital	Beijing	Beijing
China	Guangzhou Aier Eye Hospital	Guanzhou	Guangdong
China	Harbin Aier Eye Hospital	Harbin	Heilongjiang
China	Shenzhen Aier Eye Hospital	Shenzhen	Guangdong
China	Shenzhen Eye Hospital	Shenzhen	Guangdong
China	The Eye Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wuhan General Hospital of PLA	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mean BCVA	Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)	12 months
Secondary	Change of Central Rerina Thickness	Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)	12 months
Secondary	regression of Branch vacular network(BVN)	Size of Branch vascular network (um)	12 months
Secondary	Polyps regression	Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)	12 months
Secondary	Number of re-treatments	re-treatments numbers	12 month