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Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2)

NCT ID: NCT03630952

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2021-05-19

Brief Summary

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The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

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Detailed Description

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A multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial, which will randomize approximately 1140 subjects in a ratio of 1:1:1 to receive IVT injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept. The trial includes a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (last assessment at 96 weeks) with primary efficacy analysis at 36 weeks.

Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.5 mg Conbercept

Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Group Type EXPERIMENTAL

0.5 mg Conbercept Intravitreal Injection

Intervention Type BIOLOGICAL

Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

1.0 mg Conbercept

Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Group Type EXPERIMENTAL

1.0 mg Conbercept Intravitreal Injection

Intervention Type BIOLOGICAL

Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Aflibercept

Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Group Type ACTIVE_COMPARATOR

2.0 mg Aflibercept Intravitreal Injection

Intervention Type BIOLOGICAL

Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Interventions

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0.5 mg Conbercept Intravitreal Injection

Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Intervention Type BIOLOGICAL

1.0 mg Conbercept Intravitreal Injection

Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Intervention Type BIOLOGICAL

2.0 mg Aflibercept Intravitreal Injection

Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Intervention Type BIOLOGICAL

Other Intervention Names

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Eylea®

Eligibility Criteria

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Inclusion Criteria

1. Men and women ≥ 50 years of age at the Screening visit;
2. Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit;

o Women of childbearing potential must agree to use a highly effective method of contraception throughout the study.
3. Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
4. Have active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal fluorescein angiography (FA) leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening;
5. Have a ETDRS BCVA letter score of 78 to 25 in the study eye at Screening;
6. Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria

1. Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins;
2. Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening;
4. Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
5. Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
6. Have any other cause of CNV;
7. Have had prior pars plana vitrectomy in the study eye;
8. Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye;
9. Have prior trabeculectomy or other filtration surgery in the study eye;
10. Have uncontrolled glaucoma;
11. Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
12. Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
13. Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period;
14. Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
15. Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
16. Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
17. If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu Kanghong Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Cheng, MD, PhD

Role: STUDY_DIRECTOR

Chengdu Kanghong Biotechnology Co.,Ltd.

Locations

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Kanghong Investigative Site

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Springdale, Arkansas, United States

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Arcadia, California, United States

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Arcadia, California, United States

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Bakersfield, California, United States

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Encino, California, United States

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Glendale, California, United States

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Glendora, California, United States

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Huntington Beach, California, United States

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Pasadena, California, United States

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Poway, California, United States

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Redlands, California, United States

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Redlands, California, United States

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Riverside, California, United States

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San Francisco, California, United States

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Santa Barbara, California, United States

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Colorado Springs, Colorado, United States

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Waterford, Connecticut, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Stuart, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Marietta, Georgia, United States

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Elmhurst, Illinois, United States

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Indianapolis, Indiana, United States

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New Albany, Indiana, United States

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Leawood, Kansas, United States

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Springfield, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Traverse City, Michigan, United States

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St Louis, Missouri, United States

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Reno, Nevada, United States

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Northfield, New Jersey, United States

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Teaneck, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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Liverpool, New York, United States

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Shirley, New York, United States

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Asheville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Youngstown, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Camp Hill, Pennsylvania, United States

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Kingston, Pennsylvania, United States

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Ladson, South Carolina, United States

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Rapid City, South Dakota, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Kingwood, Texas, United States

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McAllen, Texas, United States

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Midland, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Bellevue, Washington, United States

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Beijing, Beijing Municipality, China

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Shanghai, Shanghai Municipality, China

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Shanghai, Shanghai Municipality, China

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Tianjin, Tianjin Municipality, China

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Aarhus N, , Denmark

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Glostrup Municipality, , Denmark

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Roskilde, , Denmark

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Sønderborg, , Denmark

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Bordeaux, , France

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Créteil, , France

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Dijon, , France

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Marseille, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Poitiers, , France

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Saint-Cyr-sur-Loire, , France

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Strasbourg, , France

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Pécs, Baranya, Hungary

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Szeged, Csongrád megye, Hungary

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Debrecen, Hajdú-Bihar, Hungary

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Budapest, Pest County, Hungary

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Budapest, Pest County, Hungary

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Budapest, Pest County, Hungary

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Budapest, Pest County, Hungary

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Budapest, Pest County, Hungary

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Budapest, Pest County, Hungary

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Zalaegerszeg, Zala County, Hungary

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Ashkelon, Ha'Darom, Israel

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Beersheba, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Poria – Neve Oved, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Zrifin, , Israel

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Chieti, , Italy

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Florence, , Italy

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Genova, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Negrar, , Italy

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Roma, , Italy

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Roma, , Italy

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Udine, , Italy

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Bratislava, , Slovakia

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Trenčín, , Slovakia

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Žilina, , Slovakia

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Žilina, , Slovakia

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Westcliff-on-Sea, Essex, United Kingdom

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Southampton, Hampshire, United Kingdom

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Gorleston-on-Sea, Norfolk, United Kingdom

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Frimley, Surrey, United Kingdom

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Belfast, , United Kingdom

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Bradford, , United Kingdom

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Bristol, , United Kingdom

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Canterbury, , United Kingdom

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Derby, , United Kingdom

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Gorleston-on-Sea, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Sheffield, , United Kingdom

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Sunderland, , United Kingdom

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Countries

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United States Bulgaria China Czechia Denmark France Hungary Israel Italy Latvia Slovakia United Kingdom

Other Identifiers

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KHB-1802

Identifier Type: -

Identifier Source: org_study_id

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