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

November 29, 2018 updated by: Aier School of Ophthalmology, Central South University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Aier Intech Eye Hospital
    • Guangdong
      • Guanzhou, Guangdong, China
        • Guangzhou Aier Eye Hospital
      • Shenzhen, Guangdong, China, 510000
        • Shenzhen Aier Eye Hospital
      • Shenzhen, Guangdong, China, 528000
        • Shenzhen Eye Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Aier Eye Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan General Hospital of Pla
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • The Eye Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab + Triamcinolone Acetonide
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
Drug: Triamcinolone Acetonide
Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
Other Names:
  • RANTA
Drug: Ranibizumab
Intravitreal inject 0.5mg of Ranibizumab.
Other Names:
  • RAN
Active Comparator: Ranibizumab
intravitreal injection: Ranibizumab 0.5mg
Drug: Ranibizumab
Intravitreal inject 0.5mg of Ranibizumab.
Other Names:
  • RAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Central Rerina Thickness
Time Frame: 12 months
Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
12 months
regression of Branch vacular network(BVN)
Time Frame: 12 months
Size of Branch vascular network (um)
12 months
Polyps regression
Time Frame: 12 months
Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
12 months
Number of re-treatments
Time Frame: 12 month
re-treatments numbers
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier School of Ophthalmology, Central South University

Investigators

  • Study Chair: Shibo Tang, Aier School of Ophthalmology, Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 17, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2016006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wet Macular Degeneration

Clinical Trials on Triamcinolone Acetonide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe