Polypoidal Choroidal VasculopathyNCT03459144
Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
A study testing verteporfin and verteporfin and ranibizumab in people with Polypoidal Choroidal Vasculopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- verteporfin and verteporfin and ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2012to 30 Jul 2015
- Phase
- Interventional
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active macula-involved polypoidal lesions evidenced by ICGA;
- greatest linear dimension of 5400 μm or less assessed by ICGA;
- follow-up of at least 12 months.
Who cannot join
- any other ocular disease, such as ocular trauma, glaucoma, uveitis, diabetic retinopathy, angioid streaks, pathologic myopia, or presumed ocular histoplasmosis syndrome;
- any systemic contraindication to the PDT, IVR, sodium fluorescein, or indocyanine green dyes;
- any severe uncontrolled systemic disease, such as uncontrolled hypertention, coronary heart disease, liver failure, or kidney failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Photodynamic Therapy, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
The aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV.
Read the detailed description
The optimal treatment for PCV is still under debate. Little knowledge is known about the treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study is to compare the outcomes of different treatment methods including PDT, IVR and combination therapy under the "1+PRN" treatment regimen for PCV.
The study is the first prospective randomized controlled trial about different treatment methods on PCV under "1+PRN" treatment regimen. The null hypothesis of the study is that combination therapy may be the optimal treatment method for PCV. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the optimal treatment for PCV.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- verteporfin, verteporfin and ranibizumab
- Keywords
- polypoidal choroidal vasculopathy, photodynamic therapy, ranibizumab, combination therapy, cost-benefit
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verteporfinDrug
Also called ranibizumab
Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.
verteporfin and ranibizumabDrug
Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.
| Study group | Role | What they receive |
|---|---|---|
| photodynamic therapy | Experimental | Participants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen). Receives: Drug: verteporfin; Drug: verteporfin and ranibizumab |
| intravitreal ranibizumab | Experimental | Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen). Receives: Drug: verteporfin; Drug: verteporfin and ranibizumab |
| combination therapy of PDT and IVR | Experimental | Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen). Receives: Drug: verteporfin; Drug: verteporfin and ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
the best corrected visual acuity is the Primary Outcome Measure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Dec 2012
- Primary completion30 Jul 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polypoidal Choroidal VasculopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chenjin Jin, Ph.D., Study chair, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459144
- Sponsor's protocol ID
- 2017KYPJ093
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lai K, Li Y, Zhou L, Zhong X, Huang C, Xu F, Lu L, Ge J, Jin C. Comparison of the effects of photodynamic therapy, intravitreal ranibizumab and combination for polypoidal choroidal vasculopathy under 1 + PRN regimen. BMC Ophthalmol. 2018 Jun 20;18(1):144. doi: 10.1186/s12886-018-0801-7.
PubMed 29925341
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Photodynamic Therapy, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
- ClinicalTrials.gov ID
- NCT03459144
- Acronym / sponsor ID
- 2017KYPJ093
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- polypoidal choroidal vasculopathy, photodynamic therapy, ranibizumab, combination therapy, cost-benefit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 8 Mar 2018 (actual)
- 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 aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV.
Detailed description
The optimal treatment for PCV is still under debate. Little knowledge is known about the treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study is to compare the outcomes of different treatment methods including PDT, IVR and combination therapy under the "1+PRN" treatment regimen for PCV.
The study is the first prospective randomized controlled trial about different treatment methods on PCV under "1+PRN" treatment regimen. The null hypothesis of the study is that combination therapy may be the optimal treatment method for PCV. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the optimal treatment for PCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| photodynamic therapy | Experimental | Drug: verteporfin, Drug: verteporfin and ranibizumabParticipants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen). |
| intravitreal ranibizumab | Experimental | Drug: verteporfin, Drug: verteporfin and ranibizumabParticipants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen). |
| combination therapy of PDT and IVR | Experimental | Drug: verteporfin, Drug: verteporfin and ranibizumabParticipants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen). |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- active macula-involved polypoidal lesions evidenced by ICGA;
- greatest linear dimension of 5400 μm or less assessed by ICGA;
- follow-up of at least 12 months.
Key exclusion criteria (3 listed)
- any other ocular disease, such as ocular trauma, glaucoma, uveitis, diabetic retinopathy, angioid streaks, pathologic myopia, or presumed ocular histoplasmosis syndrome;
- any systemic contraindication to the PDT, IVR, sodium fluorescein, or indocyanine green dyes;
- any severe uncontrolled systemic disease, such as uncontrolled hypertention, coronary heart disease, liver failure, or kidney failure.
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 |
|---|---|---|
| verteporfinAlso: ranibizumabParticipants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）. | Drug | combination therapy of PDT and IVR, intravitreal ranibizumab, photodynamic therapy |
| verteporfin and ranibizumabParticipants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary. | Drug | combination therapy of PDT and IVR, intravitreal ranibizumab, photodynamic therapy |
Primary outcome
Best corrected visual acuity
Time frame: 12 months
the best corrected visual acuity is the Primary Outcome Measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Derived from this study: PubMed 29925341Lai K, Li Y, Zhou L, Zhong X, Huang C, Xu F, Lu L, Ge J, Jin C. Comparison of the effects of photodynamic therapy, intravitreal ranibizumab and combination for polypoidal choroidal vasculopathy under 1 + PRN regimen. BMC Ophthalmol. 2018 Jun 20;18(1):144. doi: 10.1186/s12886-018-0801-7.
- Individual participant dataSharing planned: Undecided
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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.
Chenjin Jin, Ph.D. study chair
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verteporfin and verteporfin and ranibizumab in people with Polypoidal Choroidal Vasculopathy, run by Sun Yat-sen University at 1 site 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 3 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: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Best corrected visual acuity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459144, which also lists 1 linked publication.
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 8 Mar 2018.