Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)

NCT01846273 | Completed Phase 4 Results

• 1 other identifier: CRFB002A2412
• Study Type: interventional
• Target: 321
• Locations: 7 countries
• Sites: 41

Brief Summary

This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.

Conditions

Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal choroidal vasculopathy; Visual acuity; Ranibizumab; Verteporfin PDT

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye

  Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.

  Baseline, Month 12

• Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye

  Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision.

  Baseline, Month 12

Secondary Outcomes (16)

• Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye

  Baseline, Month 24

• Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye

  Baseline, Month 24

• Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption

  Month 3, Month 12, Month 24

• Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption

  Month 3, Month 12, Month 24

• Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye

  Month 6, Month 24

Study Arms (2)

Ranibizumab + vPDT

EXPERIMENTAL

Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) determined at monthly visits based on defined retreatment criteria

Drug: Ranibizumab; Drug: Verteporfin PDT

Ranibizumab monotherapy

ACTIVE COMPARATOR

Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) determined at monthly visits based on defined retreatment criteria

Drug: Ranibizumab; Drug: Sham PDT

Interventions

Ranibizumab DRUG

Intravitreal injection of 0.5 mg ranibizumab

Also known as: Lucentis

Ranibizumab + vPDT; Ranibizumab monotherapy

Verteporfin PDT DRUG

Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)

Ranibizumab + vPDT

Sham PDT DRUG

Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)

Ranibizumab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of symptomatic macular PCV in the study eye
• A qualifying vision score at study entry
• A qualifying lesion size in the study eye at study entry

You may not qualify if:

• Active inflammation or infection in the study eye
• Uncontrolled intraocular pressure in the stuy eye
• Ocular condition in the study eye which may impact vision and confound study outcomes
• Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (41)

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 462-0825, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 466 8560, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Fukushima, Fukushima, 960-1295, Japan

Location

Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Amagasaki, Hyōgo, 660 8550, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0047, Japan

Location

Novartis Investigative Site

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Sakyo-ku, Kyoto, 606 8507, Japan

Location

Novartis Investigative Site

Tsu, Mie-ken, 514-8507, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

Novartis Investigative Site

Hirakata, Osaka, 573-1191, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 550-0024, Japan

Location

Novartis Investigative Site

Ohtsu-city, Shiga, 520-2192, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Novartis Investigative Site

Mitaka, Tokyo, 181-8611, Japan

Location

Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8666, Japan

Location

Novartis Investigative Site

Chiba, 260-8677, Japan

Location

Novartis Investigative Site

Batu Caves, Selangor, 68100, Malaysia

Location

Novartis Investigative Site

Petaling Jaya, Selangor, 46150, Malaysia

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 168751, Singapore

Location

Novartis Investigative Site

Singapore, 308433, Singapore

Location

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 02447, South Korea

Location

Novartis Investigative Site

Seoul, Seocho-gu, 06591, South Korea

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Novartis Investigative Site

Seoul, 07301, South Korea

Location

Novartis Investigative Site

Seoul, 150-950, South Korea

Location

Novartis Investigative Site

Taipei, Taiwan, ROC, 11217, Taiwan

Location

Novartis Investigative Site

Changhua, 50006, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, 10449, Taiwan

Location

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

Location

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

Location

Novartis Investigative Site

Bangkok, 10400, Thailand

Location

Related Publications (4)

• Yanagi Y, Mori R, Teo KYC, Park KH, Ngah NF, Chen SJ, Ruamviboonsuk P, Kondo N, Lee WK, Rajagopalan R, Obata R, Wong IYH, Chee C, Terasaki H, Sekiryu T, Chen SC, Lai TYY, Cheung G, Honda S. Six-year findings of polypoidal choroidal vasculopathy in the EVEREST II study: Japanese subgroup analysis. Jpn J Ophthalmol. 2025 Nov;69(6):894-901. doi: 10.1007/s10384-025-01228-w. Epub 2025 Jun 12.

  PMID: 40504425 DERIVED

• Teo KYC, Park KH, Ngah NF, Chen SJ, Ruamviboonsuk P, Mori R, Kondo N, Lee WK, Rajagopalan R, Obata R, Wong IYH, Chee C, Terasaki H, Sekiryu T, Chen SC, Yanagi Y, Honda S, Lai TYY, Cheung CMG. Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the EVEREST II Study. Ophthalmol Ther. 2024 Apr;13(4):935-954. doi: 10.1007/s40123-024-00888-0. Epub 2024 Feb 3.

  PMID: 38308746 DERIVED

• Lim TH, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Lee WK, Cheung CMG, Ngah NF, Patalauskaite R, Margaron P, Koh A; EVEREST II Study Group. Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: The EVEREST II Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):935-942. doi: 10.1001/jamaophthalmol.2020.2443.

  PMID: 32672800 DERIVED

• Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Feller C, Margaron P, Lim TH, Lee WK; EVEREST II study group. Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1206-1213. doi: 10.1001/jamaophthalmol.2017.4030.

  PMID: 28983556 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Polypoidal Choroidal Vasculopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: August 7, 2013
• Primary Completion: March 11, 2016
• Study Completion: March 2, 2017
• Last Updated: June 7, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2); HK (1); KR (5); SG (3); TW (6); TH (2); JP (22)