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

Primary Purpose

Wet Macular Degeneration

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Ranibizumab
Sponsored by
Aier School of Ophthalmology, Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring Polypoidal Choroidal Vasculopathy

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Beijing Aier Intech Eye Hospital
  • Guangzhou Aier Eye Hospital
  • Shenzhen Aier Eye Hospital
  • Shenzhen Eye Hospital
  • Harbin Aier Eye Hospital
  • Wuhan General Hospital of PLA
  • The Eye Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ranibizumab + Triamcinolone Acetonide

Ranibizumab

Arm Description

intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg

intravitreal injection: Ranibizumab 0.5mg

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2016
Last Updated
November 29, 2018
Sponsor
Aier School of Ophthalmology, Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02806752
Brief Title
Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy
Acronym
RANTA
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aier School of Ophthalmology, Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration
Keywords
Polypoidal Choroidal Vasculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab + Triamcinolone Acetonide
Arm Type
Experimental
Arm Description
intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
intravitreal injection: Ranibizumab 0.5mg
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
RANTA
Intervention Description
Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
RAN
Intervention Description
Intravitreal inject 0.5mg of Ranibizumab.
Primary Outcome Measure Information:
Title
Change of mean BCVA
Description
Change of Central BCVA (Measured with EDTRS Chart,numbers of letters) (primary: baseline and 6 months, secondary: baseline to 12 months)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of Central Rerina Thickness
Description
Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
Time Frame
12 months
Title
regression of Branch vacular network(BVN)
Description
Size of Branch vascular network (um)
Time Frame
12 months
Title
Polyps regression
Description
Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
Time Frame
12 months
Title
Number of re-treatments
Description
re-treatments numbers
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shibo Tang
Organizational Affiliation
Aier School of Ophthalmology, Central South University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Aier Intech Eye Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Guangzhou Aier Eye Hospital
City
Guanzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen Aier Eye Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Shenzhen Eye Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Harbin Aier Eye Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Wuhan General Hospital of PLA
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Eye Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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