Wet Macular DegenerationPhase 4RANTANCT02806752
Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal Vasculopathy
A Phase 4 study testing Triamcinolone Acetonide and Ranibizumab in people with Wet Macular Degeneration, run by Aier School of Ophthalmology, Central South University at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Triamcinolone Acetonide and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesChina
- Study dates
- Jan 2017to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Aier Intech Eye Hospital
Beijing, Beijing Municipality
Guangzhou Aier Eye Hospital
Guanzhou, Guangdong
Harbin Aier Eye Hospital
Harbin, Heilongjiang
Shenzhen Aier Eye Hospital
Shenzhen, Guangdong, 510000
Shenzhen Eye Hospital
Shenzhen, Guangdong, 528000
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Wuhan General Hospital of PLA
Wuhan, Hubei
About this study
Official title: 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.
Read the 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
- Being tested
- Triamcinolone Acetonide, Ranibizumab
- Keywords
- Polypoidal Choroidal Vasculopathy
- Medical subject headings
- Wet Macular Degeneration, Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called RANTA
Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
RanibizumabDrug
Also called RAN
Intravitreal inject 0.5mg of Ranibizumab.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab + Triamcinolone Acetonide | Experimental | intravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg Receives: Drug: Triamcinolone Acetonide; Drug: Ranibizumab |
| Ranibizumab | Active comparator | intravitreal injection: Ranibizumab 0.5mg Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (4)
Change of Central Rerina Thickness
Change of Central Rerina Thickness (um) (primary: between baseline and 6 months, secondary: between baseline to 12 months)
Measured: 12 months
regression of Branch vacular network(BVN)
Size of Branch vascular network (um)
Measured: 12 months
Polyps regression
Size of polyps (um)(primary: between baseline and 6 months, secondary: between baseline to 12 months)
Measured: 12 months
Number of re-treatments
re-treatments numbers
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shibo Tang, Study chair, Aier School of Ophthalmology, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806752
- Sponsor's protocol ID
- IRB2016006
- Acronym
- RANTA
- Status last verified
- Nov 2018
- First submitted
- 17 Apr 2016
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Study of Intravitreal Ranibizumab and Triamcinolone Acetonide Combination Therapy Versus Ranibizumab Monotherapy in Patients With Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT02806752
- Acronym / sponsor ID
- RANTA / IRB2016006
- Conditions
- Wet Macular Degeneration
- Keywords
- Polypoidal Choroidal Vasculopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab + Triamcinolone Acetonide | Experimental | Drug: Triamcinolone Acetonide, Drug: Ranibizumabintravitreal injection: Ranibizumab 0.5mg + Triamcinolone Acetonide 2mg |
| Ranibizumab | Active comparator | Drug: Ranibizumabintravitreal injection: Ranibizumab 0.5mg |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone AcetonideAlso: RANTAIntravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide. | Drug | Ranibizumab + Triamcinolone Acetonide |
| RanibizumabAlso: RANIntravitreal inject 0.5mg of Ranibizumab. | Drug | Ranibizumab, Ranibizumab + Triamcinolone Acetonide |
Primary outcome
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)
4 secondary outcomes
Change of Central Rerina Thickness
Time frame: 12 months
regression of Branch vacular network(BVN)
Time frame: 12 months
Polyps regression
Time frame: 12 months
Number of re-treatments
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shibo Tang study chair
Aier School of Ophthalmology, Central South University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide and Ranibizumab in people with Wet Macular Degeneration, run by Aier School of Ophthalmology, Central South University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean BCVA (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.