Initial Versus Delayed PDT Combination With Conbercept in PCV

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

Efficacy and Safety of Initial Versus Delayed Verteporfin Photodynamic Therapy in Combination With Conbercept in Patients With Symptomatic Polypoidal Choroidal Vasculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821520
• Other study ID #: Y-2016020
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: The Eye Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Either gender,age = 40.

2. BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).

3. Naive symptomatic PCV patients.

4. Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.

5. No refractive media opacity or small pupil narrow that influence the fundus examination.

6. Women must be using effective contraception, be post-menopausal for at least months prior to trial entry, or surgically sterile.

7. Ability to provide written informed consent and to return for all study visits.

Exclusion Criteria:

1. Active inflammation or infection in the study eye.

2. Uncontrolled intraocular pressure (>25 mmHg) in the study eye.

3. 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).

4. Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.

5. 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.

6. Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.

7. Allergy to fluorescein, ICG, iodine, shellfish.

8. Pregnant or breast-feeding women.

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• conbercept
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.

Procedure:
• Initial PDT
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 PDT
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.

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The first affiliated hospital of Shanghai Jiaotong University	Shanghai	Shanghai
China	The Eye Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (12)

Ciardella AP, Donsoff IM, Huang SJ, Costa DL, Yannuzzi LA. Polypoidal choroidal vasculopathy. Surv Ophthalmol. 2004 Jan-Feb;49(1):25-37. Review. — View Citation

Gomi 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. — View Citation

Gomi F, Tano Y. Polypoidal choroidal vasculopathy and treatments. Curr Opin Ophthalmol. 2008 May;19(3):208-12. doi: 10.1097/ICU.0b013e3282fb7c33. Review. — View Citation

Imamura 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. Review. — View Citation

Koh 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. — View Citation

Koh 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. — View Citation

Laude 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. Review. — View Citation

Oishi 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. — View Citation

Qu 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. — View Citation

Yannuzzi 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. — View Citation

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. Review. — View Citation

Yannuzzi 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Corrected Visual Acuity (BCVA) in each group,Compare the difference between the two groups.		from baseline (month 0) to month 12
Secondary	The proportion of polyps regression assessed by ICGA in each group.Compare the difference between the two groups.		from Baseline (month 0) to month 12
Secondary	Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)		from Baseline baseline (month 0) to month 12
Secondary	Total number of treatments with PDT and conbercept respectively		from Baseline (month 0) to month 12
Secondary	Change in Best Corrected Visual Acuity (BCVA) at month 3		from Baseline baseline (month 0) to month 3
Secondary	Polyps regression, assessed by Indocyanine Green Angiography (ICGA)		from baseline (month 0) to month 3
Secondary	Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)		from baseline (month 0) to month 3
Secondary	Frequency and severity of ocular and non-ocular adverse events over time.		from baseline (month 0) to month 12