Polypoidal Choroidal VasculopathyPhase 4NCT02821520
Initial Versus Delayed PDT Combination With Conbercept in PCV
A Phase 4 study testing conbercept, Initial PDT and Delayed PDT in people with Polypoidal Choroidal Vasculopathy, run by The Eye Hospital of Wenzhou Medical University at 3 sites in China.
Trial summary
To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- conbercept, Initial PDT and Delayed PDT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2017to Jun 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either gender，age ≥ 40.
- BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).
- Naive symptomatic PCV patients.
- Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.
- No refractive media opacity or small pupil narrow that influence the fundus examination.
- Women must be using effective contraception, be post-menopausal for at least months prior to trial entry, or surgically sterile.
- Ability to provide written informed consent and to return for all study visits.
Who cannot join
- Active inflammation or infection in the study eye.
- Uncontrolled intraocular pressure (>25 mmHg) in the study eye.
- Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epiretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
- Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.
- Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
- Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
- Allergy to fluorescein, ICG, iodine, shellfish.
- Pregnant or breast-feeding women.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang
The first affiliated hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: Efficacy and Safety of Initial Versus Delayed Verteporfin Photodynamic Therapy in Combination With Conbercept in Patients With Symptomatic Polypoidal Choroidal Vasculopathy
To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).
Read the detailed description
Polypoidal choroidal vasculopathy (PCV) is characterized by polypoidal choroidal vascular dilatation with or without abnormally branching vascular networks(BVN) on indocyanine green angiography (ICGA). It has been considered to be a subtype of wet age-related macular degeneration(wAMD). PCV is more prevalent in Asian patients than in white patients; nearly half of Chinese patients who was diagnosed with wAMD actually was PCV.
However, recently, the first choice treatment for wAMD has shifted to anti-vascular endothelial growth factor (VEGF) drugs, such as bevacizumab(Avastin,Genentech Inc), ranibizumab (Lucentis, Genentech Inc)and aflibercept (Eylea, Regeneron,Berlin,Germany) from PDT, and the vision improving effect has been confirmed regardless of race or disease subtype. Therefore, eyes with PCV can be treated initially with anti-VEGF drugs, however, they are limited in their ability to resolve polypoidal lesions, for which PDT works effectively.
Combination therapy of PDT and anti-VEGF drugs provides the complementary effects of both treatments, but it remains unknown whether PDT should have been administered at the beginning of treatment or during follow-up of anti-VEGF therapy. The purpose of this study was to compare the 12-months treatment results of initial and delayed PDT combined with conbercept (Lumitin, Chengdu Kang Hong Biotech Co., Ltd., Sichuan, China) for PCV.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- conbercept, Initial PDT, Delayed PDT
- Keywords
- Polypoidal Choroidal Vasculopathy, Photodynamic Therapy, Conbercept, Efficacy, Safety, vascular endothelial growth factor
- 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.
conberceptDrug
Also called lumitin
At baseline conbercept injection is administered.And thereafter is administered based on re-treatment criteria from month 1 to 11.The PRN conbercept re-injection should be monthly.
Initial PDTProcedure or surgery
Also called verteporfin
At baseline PDT with verteporfin is administered initially.And thereafter PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months.
Delayed PDTProcedure or surgery
Also called verteporfin
PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Initial PDT combination with Conbercept | Experimental | 1. Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11.
2. PDT: PDT with verteporfin is administered at baseline and then PRN PDT combination with conbercept injection based on retreatment criteria from month 3 to 11.
PDT treatment must be administered within 7 days after the injection. If same day treatment of conbercept and PDT is performed, conbercept injection is to be administered at least 2 hours after the PDT.
PDT should cover the whole area of polyps and branch vascular net (BVN).The PRN PDT retreatment intervals should be no less than 3 months. Receives: Drug: conbercept; Procedure: Initial PDT |
| Delayed PDT combination with Conbercept | Active comparator | 1. Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11.
2. PDT:PRN PDT combination with conbercept injection based on retreatment criteria from month 3 to 11.
PDT treatment must be administered within 7 days after the injection. If same day treatment of conbercept and PDT is performed, conbercept injection is to be administered at least 2 hours after the PDT.
PDT should cover the whole area of polyps and branch vascular net (BVN).The PRN PDT retreatment intervals should be no less than 3 months. Receives: Drug: conbercept; Procedure: Delayed PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity (BCVA) in each group,Compare the difference between the two groups.
Measured: from baseline (month 0) to month 12
Secondary outcomes (7)
The proportion of polyps regression assessed by ICGA in each group.Compare the difference between the two groups.
Measured: from Baseline (month 0) to month 12
Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)
Measured: from Baseline baseline (month 0) to month 12
Total number of treatments with PDT and conbercept respectively
Measured: from Baseline (month 0) to month 12
Change in Best Corrected Visual Acuity (BCVA) at month 3
Measured: from Baseline baseline (month 0) to month 3
Polyps regression, assessed by Indocyanine Green Angiography (ICGA)
Measured: from baseline (month 0) to month 3
Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)
Measured: from baseline (month 0) to month 3
Frequency and severity of ocular and non-ocular adverse events over time.
Measured: from baseline (month 0) to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Polypoidal Choroidal VasculopathyStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Liu, The Eye Hospital of Wenzhou Medical University
- Investigators
- Xiaoling Liu, Professor, Principal investigator, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821520
- Sponsor's protocol ID
- Y-2016020
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2016
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yannuzzi LA, Sorenson JA, Guyer DR, Slakter JS, Chang B, Orlock D. Indocyanine green videoangiography: current status. Eur J Ophthalmol. 1994 Apr-Jun;4(2):69-81. doi: 10.1177/112067219400400201.
PubMed 7950339Yannuzzi LA, Ciardella A, Spaide RF, Rabb M, Freund KB, Orlock DA. The expanding clinical spectrum of idiopathic polypoidal choroidal vasculopathy. Arch Ophthalmol. 1997 Apr;115(4):478-85. doi: 10.1001/archopht.1997.01100150480005.
PubMed 9109756Yannuzzi LA, Wong DW, Sforzolini BS, Goldbaum M, Tang KC, Spaide RF, Freund KB, Slakter JS, Guyer DR, Sorenson JA, Fisher Y, Maberley D, Orlock DA. Polypoidal choroidal vasculopathy and neovascularized age-related macular degeneration. Arch Ophthalmol. 1999 Nov;117(11):1503-10. doi: 10.1001/archopht.117.11.1503.
PubMed 10565519Ciardella AP, Donsoff IM, Huang SJ, Costa DL, Yannuzzi LA. Polypoidal choroidal vasculopathy. Surv Ophthalmol. 2004 Jan-Feb;49(1):25-37. doi: 10.1016/j.survophthal.2003.10.007.
PubMed 14711438Imamura Y, Engelbert M, Iida T, Freund KB, Yannuzzi LA. Polypoidal choroidal vasculopathy: a review. Surv Ophthalmol. 2010 Nov-Dec;55(6):501-15. doi: 10.1016/j.survophthal.2010.03.004. Epub 2010 Sep 20.
PubMed 20850857Gomi F, Tano Y. Polypoidal choroidal vasculopathy and treatments. Curr Opin Ophthalmol. 2008 May;19(3):208-12. doi: 10.1097/ICU.0b013e3282fb7c33.
PubMed 18408495Laude A, Cackett PD, Vithana EN, Yeo IY, Wong D, Koh AH, Wong TY, Aung T. Polypoidal choroidal vasculopathy and neovascular age-related macular degeneration: same or different disease? Prog Retin Eye Res. 2010 Jan;29(1):19-29. doi: 10.1016/j.preteyeres.2009.10.001. Epub 2009 Oct 23.
PubMed 19854291Koh AH; Expert PCV Panel; Chen LJ, Chen SJ, Chen Y, Giridhar A, Iida T, Kim H, Yuk Yau Lai T, Lee WK, Li X, Han Lim T, Ruamviboonsuk P, Sharma T, Tang S, Yuzawa M. Polypoidal choroidal vasculopathy: evidence-based guidelines for clinical diagnosis and treatment. Retina. 2013 Apr;33(4):686-716. doi: 10.1097/IAE.0b013e3182852446.
PubMed 23455233Qu J, Cheng Y, Li X, Yu L, Ke X; AURORA Study Group. EFFICACY OF INTRAVITREAL INJECTION OF CONBERCEPT IN POLYPOIDAL CHOROIDAL VASCULOPATHY: Subgroup Analysis of the Aurora Study. Retina. 2016 May;36(5):926-37. doi: 10.1097/IAE.0000000000000875.
PubMed 26595362Gomi F, Oshima Y, Mori R, Kano M, Saito M, Yamashita A, Iwata E, Maruko R; Fujisan Study Group. INITIAL VERSUS DELAYED PHOTODYNAMIC THERAPY IN COMBINATION WITH RANIBIZUMAB FOR TREATMENT OF POLYPOIDAL CHOROIDAL VASCULOPATHY: The Fujisan Study. Retina. 2015 Aug;35(8):1569-76. doi: 10.1097/IAE.0000000000000526.
PubMed 25830698Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8.
PubMed 22426346Oishi A, Kojima H, Mandai M, Honda S, Matsuoka T, Oh H, Kita M, Nagai T, Fujihara M, Bessho N, Uenishi M, Kurimoto Y, Negi A. Comparison of the effect of ranibizumab and verteporfin for polypoidal choroidal vasculopathy: 12-month LAPTOP study results. Am J Ophthalmol. 2013 Oct;156(4):644-51. doi: 10.1016/j.ajo.2013.05.024. Epub 2013 Jul 20.
PubMed 23876867Sun Z, Gong Y, Yang Y, Huang Y, Yu S, Pei J, Lin B, Zhou R, Li Y, Li Y, Zhang J, Liu X. Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy. Front Med (Lausanne). 2022 Feb 9;8:791935. doi: 10.3389/fmed.2021.791935. eCollection 2021.
PubMed 35223882
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Initial Versus Delayed Verteporfin Photodynamic Therapy in Combination With Conbercept in Patients With Symptomatic Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT02821520
- Acronym / sponsor ID
- Y-2016020
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- Polypoidal Choroidal Vasculopathy, Photodynamic Therapy, Conbercept, Efficacy, Safety, vascular endothelial growth factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Eye Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 1 Jul 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.
To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).
Detailed description
Polypoidal choroidal vasculopathy (PCV) is characterized by polypoidal choroidal vascular dilatation with or without abnormally branching vascular networks(BVN) on indocyanine green angiography (ICGA). It has been considered to be a subtype of wet age-related macular degeneration(wAMD). PCV is more prevalent in Asian patients than in white patients; nearly half of Chinese patients who was diagnosed with wAMD actually was PCV.
However, recently, the first choice treatment for wAMD has shifted to anti-vascular endothelial growth factor (VEGF) drugs, such as bevacizumab(Avastin,Genentech Inc), ranibizumab (Lucentis, Genentech Inc)and aflibercept (Eylea, Regeneron,Berlin,Germany) from PDT, and the vision improving effect has been confirmed regardless of race or disease subtype. Therefore, eyes with PCV can be treated initially with anti-VEGF drugs, however, they are limited in their ability to resolve polypoidal lesions, for which PDT works effectively.
Combination therapy of PDT and anti-VEGF drugs provides the complementary effects of both treatments, but it remains unknown whether PDT should have been administered at the beginning of treatment or during follow-up of anti-VEGF therapy. The purpose of this study was to compare the 12-months treatment results of initial and delayed PDT combined with conbercept (Lumitin, Chengdu Kang Hong Biotech Co., Ltd., Sichuan, China) for PCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial PDT combination with Conbercept | Experimental | Drug: conbercept, Procedure: Initial PDT1. Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11. 2. PDT: PDT with verteporfin is administered at baseline and then PRN PDT combination with conbercept injection based on retreatment criteria from month 3 to 11. PDT treatment must be administered within 7 days after the injection. If same day treatment of conbercept and PDT is performed, conbercept injection is to be administered at least 2 hours after the PDT. PDT should cover the whole area of polyps and branch vascular net (BVN).The PRN PDT retreatment intervals should be no less than 3 months. |
| Delayed PDT combination with Conbercept | Active comparator | Drug: conbercept, Procedure: Delayed PDT1. Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11. 2. PDT:PRN PDT combination with conbercept injection based on retreatment criteria from month 3 to 11. PDT treatment must be administered within 7 days after the injection. If same day treatment of conbercept and PDT is performed, conbercept injection is to be administered at least 2 hours after the PDT. PDT should cover the whole area of polyps and branch vascular net (BVN).The PRN PDT retreatment intervals should be no less than 3 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Either gender，age ≥ 40.
- BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).
- Naive symptomatic PCV patients.
- Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.
- No refractive media opacity or small pupil narrow that influence the fundus examination.
Key exclusion criteria (8 listed)
- Active inflammation or infection in the study eye.
- Uncontrolled intraocular pressure (>25 mmHg) in the study eye.
- Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epiretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
- Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.
- Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
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 |
|---|---|---|
| conberceptAlso: lumitinAt baseline conbercept injection is administered.And thereafter is administered based on re-treatment criteria from month 1 to 11.The PRN conbercept re-injection should be monthly. | Drug | Delayed PDT combination with Conbercept, Initial PDT combination with Conbercept |
| Initial PDTAlso: verteporfinAt baseline PDT with verteporfin is administered initially.And thereafter PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months. | Procedure or surgery | Initial PDT combination with Conbercept |
| Delayed PDTAlso: verteporfinPDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months. | Procedure or surgery | Delayed PDT combination with Conbercept |
Primary outcome
Change in Best Corrected Visual Acuity (BCVA) in each group,Compare the difference between the two groups.
Time frame: from baseline (month 0) to month 12
7 secondary outcomes
The proportion of polyps regression assessed by ICGA in each group.Compare the difference between the two groups.
Time frame: from Baseline (month 0) to month 12
Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)
Time frame: from Baseline baseline (month 0) to month 12
Total number of treatments with PDT and conbercept respectively
Time frame: from Baseline (month 0) to month 12
Change in Best Corrected Visual Acuity (BCVA) at month 3
Time frame: from Baseline baseline (month 0) to month 3
Polyps regression, assessed by Indocyanine Green Angiography (ICGA)
Time frame: from baseline (month 0) to month 3
Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)
Time frame: from baseline (month 0) to month 3
Frequency and severity of ocular and non-ocular adverse events over time.
Time frame: from baseline (month 0) to month 12
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 19 Jul 2019.
- Background: PubMed 7950339Yannuzzi LA, Sorenson JA, Guyer DR, Slakter JS, Chang B, Orlock D. Indocyanine green videoangiography: current status. Eur J Ophthalmol. 1994 Apr-Jun;4(2):69-81. doi: 10.1177/112067219400400201.
- Background: PubMed 9109756Yannuzzi LA, Ciardella A, Spaide RF, Rabb M, Freund KB, Orlock DA. The expanding clinical spectrum of idiopathic polypoidal choroidal vasculopathy. Arch Ophthalmol. 1997 Apr;115(4):478-85. doi: 10.1001/archopht.1997.01100150480005.
- Background: PubMed 10565519Yannuzzi LA, Wong DW, Sforzolini BS, Goldbaum M, Tang KC, Spaide RF, Freund KB, Slakter JS, Guyer DR, Sorenson JA, Fisher Y, Maberley D, Orlock DA. Polypoidal choroidal vasculopathy and neovascularized age-related macular degeneration. Arch Ophthalmol. 1999 Nov;117(11):1503-10. doi: 10.1001/archopht.117.11.1503.
- Background: PubMed 14711438Ciardella AP, Donsoff IM, Huang SJ, Costa DL, Yannuzzi LA. Polypoidal choroidal vasculopathy. Surv Ophthalmol. 2004 Jan-Feb;49(1):25-37. doi: 10.1016/j.survophthal.2003.10.007.
- Background: PubMed 20850857Imamura Y, Engelbert M, Iida T, Freund KB, Yannuzzi LA. Polypoidal choroidal vasculopathy: a review. Surv Ophthalmol. 2010 Nov-Dec;55(6):501-15. doi: 10.1016/j.survophthal.2010.03.004. Epub 2010 Sep 20.
- Background: PubMed 18408495Gomi F, Tano Y. Polypoidal choroidal vasculopathy and treatments. Curr Opin Ophthalmol. 2008 May;19(3):208-12. doi: 10.1097/ICU.0b013e3282fb7c33.
- Background: PubMed 19854291Laude A, Cackett PD, Vithana EN, Yeo IY, Wong D, Koh AH, Wong TY, Aung T. Polypoidal choroidal vasculopathy and neovascular age-related macular degeneration: same or different disease? Prog Retin Eye Res. 2010 Jan;29(1):19-29. doi: 10.1016/j.preteyeres.2009.10.001. Epub 2009 Oct 23.
- Background: PubMed 23455233Koh AH; Expert PCV Panel; Chen LJ, Chen SJ, Chen Y, Giridhar A, Iida T, Kim H, Yuk Yau Lai T, Lee WK, Li X, Han Lim T, Ruamviboonsuk P, Sharma T, Tang S, Yuzawa M. Polypoidal choroidal vasculopathy: evidence-based guidelines for clinical diagnosis and treatment. Retina. 2013 Apr;33(4):686-716. doi: 10.1097/IAE.0b013e3182852446.
- Background: PubMed 26595362Qu J, Cheng Y, Li X, Yu L, Ke X; AURORA Study Group. EFFICACY OF INTRAVITREAL INJECTION OF CONBERCEPT IN POLYPOIDAL CHOROIDAL VASCULOPATHY: Subgroup Analysis of the Aurora Study. Retina. 2016 May;36(5):926-37. doi: 10.1097/IAE.0000000000000875.
- Background: PubMed 25830698Gomi F, Oshima Y, Mori R, Kano M, Saito M, Yamashita A, Iwata E, Maruko R; Fujisan Study Group. INITIAL VERSUS DELAYED PHOTODYNAMIC THERAPY IN COMBINATION WITH RANIBIZUMAB FOR TREATMENT OF POLYPOIDAL CHOROIDAL VASCULOPATHY: The Fujisan Study. Retina. 2015 Aug;35(8):1569-76. doi: 10.1097/IAE.0000000000000526.
- Background: PubMed 22426346Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8.
- Background: PubMed 23876867Oishi A, Kojima H, Mandai M, Honda S, Matsuoka T, Oh H, Kita M, Nagai T, Fujihara M, Bessho N, Uenishi M, Kurimoto Y, Negi A. Comparison of the effect of ranibizumab and verteporfin for polypoidal choroidal vasculopathy: 12-month LAPTOP study results. Am J Ophthalmol. 2013 Oct;156(4):644-51. doi: 10.1016/j.ajo.2013.05.024. Epub 2013 Jul 20.
- 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.
Xiaoling Liu, Professor principal investigator
The Eye Hospital of Wenzhou Medical University
3 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 conbercept, Initial PDT and Delayed PDT in people with Polypoidal Choroidal Vasculopathy, run by The Eye Hospital of Wenzhou Medical University at 3 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 7 inclusion and 8 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Change in Best Corrected Visual Acuity (BCVA) in each group,Compare the difference between the two groups. (time frame: from baseline (month 0) to month 12). 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 NCT02821520, which also lists 13 linked publications.
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 19 Jul 2019.