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

NCT02806752 | Unknown Phase 4 DMC

• 1 other identifier: IRB2016006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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.

Conditions

Wet Macular Degeneration

Keywords

Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of Central Rerina Thickness

  12 months

• regression of Branch vacular network(BVN)

  12 months

• Polyps regression

  12 months

• Number of re-treatments

  12 month

Study Arms (2)

Ranibizumab + Triamcinolone Acetonide

EXPERIMENTAL

intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg

Drug: Triamcinolone Acetonide; Drug: Ranibizumab

Ranibizumab

ACTIVE COMPARATOR

intravitreal injection: Ranibizumab 0.5mg

Drug: Ranibizumab

Interventions

Triamcinolone Acetonide DRUG

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

Also known as: RANTA

Ranibizumab + Triamcinolone Acetonide

Ranibizumab DRUG

Intravitreal inject 0.5mg of Ranibizumab.

Also known as: RAN

Ranibizumab; Ranibizumab + Triamcinolone Acetonide

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aier School of Ophthalmology, Central South University: lead

Study Sites (7)

Beijing Aier Intech Eye Hospital

Beijing, Beijing Municipality, China

Location

Guangzhou Aier Eye Hospital

Guanzhou, Guangdong, China

Location

Shenzhen Aier Eye Hospital

Shenzhen, Guangdong, 510000, China

Location

Shenzhen Eye Hospital

Shenzhen, Guangdong, 528000, China

Location

Harbin Aier Eye Hospital

Harbin, Heilongjiang, China

Location

Wuhan General Hospital of PLA

Wuhan, Hubei, China

Location

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Wet Macular Degeneration; Polypoidal Choroidal Vasculopathy

Interventions

Triamcinolone Acetonide; Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shibo Tang

  Aier School of Ophthalmology, Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: June 21, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)