Neovascular Age-related Macular DegenerationPhase 3NCT03630952

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

A Phase 3 study testing 0.5 mg Conbercept Intravitreal Injection, 1.0 mg Conbercept Intravitreal Injection and 2.0 mg Aflibercept Intravitreal Injection in people with Neovascular Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 154 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Neovascular Age-related Macular Degeneration
What is being tested?: 0.5 mg Conbercept Intravitreal Injection, 1.0 mg Conbercept Intravitreal Injection and 2.0 mg Aflibercept Intravitreal Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,157 participants
Where: 154 sitesin 12 countries
Study dates: 21 Dec 2018to 19 May 2021
Phase: Phase 3
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women ≥ 50 years of age at the Screening visit;
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.
Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
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;
Have a ETDRS BCVA letter score of 78 to 25 in the study eye at Screening;
Are willing and able to sign the study written informed consent form (ICF).

Who cannot join

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;
Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
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;
Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
Have any other cause of CNV;

Show all 17Show fewer

Have had prior pars plana vitrectomy in the study eye;
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;
Have prior trabeculectomy or other filtration surgery in the study eye;
Have uncontrolled glaucoma;
Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
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.
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;
Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding.

Trial locations and contacts

154 sites in 12 countries.

Country

City, postcode or hospital

154 sites in 12 countries

United States69 sites

Kanghong Investigative Site
Albuquerque, New Mexico, 87109
Kanghong Investigative Site
Arcadia, California, 91006
Kanghong Investigative Site
Arcadia, California, 91007
Kanghong Investigative Site
Arlington, Texas, 76012
Kanghong Investigative Site
Asheville, North Carolina, 28803
Kanghong Investigative Site
Atlanta, Georgia, 30328
Kanghong Investigative Site
Augusta, Georgia, 30909
Kanghong Investigative Site
Austin, Texas, 78705
Kanghong Investigative Site
Austin, Texas, 78731
Kanghong Investigative Site
Bakersfield, California, 93309
Kanghong Investigative Site
Bellaire, Texas, 77401
Kanghong Investigative Site
Bellevue, Washington, 98004
Kanghong Investigative Site
Boynton Beach, Florida, 33426
Kanghong Investigative Site
Bradenton, Florida, 34209
Kanghong Investigative Site
Brooklyn, New York, 11201
Kanghong Investigative Site
Burlington, Vermont, 05401
Kanghong Investigative Site
Camp Hill, Pennsylvania, 17011
Kanghong Investigative Site
Charlottesville, Virginia, 22903
Kanghong Investigative Site
Colorado Springs, Colorado, 80909
Kanghong Investigative Site
Dallas, Texas, 75231
Kanghong Investigative Site
Elmhurst, Illinois, 60126
Kanghong Investigative Site
Encino, California, 91436
Kanghong Investigative Site
Fort Worth, Texas, 76102
Kanghong Investigative Site
Glendale, California, 91203
Kanghong Investigative Site
Glendora, California, 91741
Kanghong Investigative Site
Grand Rapids, Michigan, 49546
Kanghong Investigative Site
Great Neck, New York, 11021
Kanghong Investigative Site
Huntington Beach, California, 92647
Kanghong Investigative Site
Indianapolis, Indiana, 46290
Kanghong Investigative Site
Kingston, Pennsylvania, 18704
Kanghong Investigative Site
Kingwood, Texas, 77339
Kanghong Investigative Site
Ladson, South Carolina, 29456
Kanghong Investigative Site
Leawood, Kansas, 66211
Kanghong Investigative Site
Liverpool, New York, 13088
Kanghong Investigative Site
Marietta, Georgia, 30060
Kanghong Investigative Site
McAllen, Texas, 78503
Kanghong Investigative Site
Medford, Oregon, 97504
Kanghong Investigative Site
Miami, Florida, 33126
Kanghong Investigative Site
Miami, Florida, 33143
Kanghong Investigative Site
Midland, Texas, 79706
Kanghong Investigative Site
New Albany, Indiana, 47150
Kanghong Investigative Site
Northfield, New Jersey, 08205
Kanghong Investigative Site
Oklahoma City, Oklahoma, 73104
Kanghong Investigative Site
Pasadena, California, 91107
Kanghong Investigative Site
Phoenix, Arizona, 85020
Kanghong Investigative Site
Phoenix, Arizona, 85021
Kanghong Investigative Site
Portland, Oregon, 97225
Kanghong Investigative Site
Poway, California, 92064
Kanghong Investigative Site
Rapid City, South Dakota, 57701
Kanghong Investigative Site
Redlands, California, 92373
Kanghong Investigative Site
Redlands, California, 92374
Kanghong Investigative Site
Reno, Nevada, 89502
Kanghong Investigative Site
Riverside, California, 92505
Kanghong Investigative Site
Salt Lake City, Utah, 84107
Kanghong Investigative Site
San Francisco, California, 94109
Kanghong Investigative Site
Santa Barbara, California, 93013
Kanghong Investigative Site
Shirley, New York, 11967
Kanghong Investigative Site
Springdale, Arkansas, 72762
Kanghong Investigative Site
Springfield, Massachusetts, 01107
Kanghong Investigative Site
Springfield, Oregon, 97477
Kanghong Investigative Site
St Louis, Missouri, 63128
Kanghong Investigative Site
Stuart, Florida, 34994
Kanghong Investigative Site
Teaneck, New Jersey, 07666
Kanghong Investigative Site
Temple, Texas, 76502
Kanghong Investigative Site
Traverse City, Michigan, 49686
Kanghong Investigative Site
Waterford, Connecticut, 06385
Kanghong Investigative Site
Winston-Salem, North Carolina, 27157
Kanghong Investigative Site
Winter Haven, Florida, 33880
Kanghong Investigative Site
Youngstown, Ohio, 44505

Other trials in United States

United Kingdom16 sites

Kanghong Investigative Site
Belfast, BT12 6BA
Kanghong Investigative Site
Bradford, BD9 6RJ
Kanghong Investigative Site
Bristol, BS1 2LX
Kanghong Investigative Site
Canterbury, CT1 3NG
Kanghong Investigative Site
Derby, DE22 3NE
Kanghong Investigative Site
Frimley, Surrey, GU16 7UJ
Kanghong Investigative Site
Gorleston-on-Sea, Norfolk, NR31 6LA
Kanghong Investigative Site
Gorleston-on-Sea, NR31 6LA
Kanghong Investigative Site
Leeds, LS9 7TF
Kanghong Investigative Site
London, EC1V 2PD
Kanghong Investigative Site
London, NW1 5QH
Kanghong Investigative Site
London, NW10 7NS
Kanghong Investigative Site
Sheffield, S10 2JF
Kanghong Investigative Site
Southampton, Hampshire, SO16 6YD
Kanghong Investigative Site
Sunderland, SR2 9HP
Kanghong Investigative Site
Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

Israel13 sites

Kanghong Investigative Site
Ashkelon, Ha'Darom, 7830604
Kanghong Investigative Site
Beersheba, 8457108
Kanghong Investigative Site
Haifa, 31048
Kanghong Investigative Site
Haifa, 31096
Kanghong Investigative Site
Haifa, 3436212
Kanghong Investigative Site
Jerusalem, 9103102
Kanghong Investigative Site
Jerusalem, 9112001
Kanghong Investigative Site
Kfar Saba, 4428164
Kanghong Investigative Site
Petah Tikva, 4941492
Kanghong Investigative Site
Poria – Neve Oved, 1520800
Kanghong Investigative Site
Rehovot, 76100
Kanghong Investigative Site
Tel Aviv, 64239
Kanghong Investigative Site
Zrifin, 7030000

Other trials in Israel

France11 sites

Kanghong Investigative Site
Bordeaux, 33000
Kanghong Investigative Site
Créteil, 94010
Kanghong Investigative Site
Dijon, 21079
Kanghong Investigative Site
Marseille, 13008
Kanghong Investigative Site
Paris, 75010
Kanghong Investigative Site
Paris, 75012
Kanghong Investigative Site
Paris, 75015
Kanghong Investigative Site
Paris, 75019
Kanghong Investigative Site
Poitiers, 86021
Kanghong Investigative Site
Saint-Cyr-sur-Loire, 37540
Kanghong Investigative Site
Strasbourg, 67000

Other trials in France

Hungary10 sites

Kanghong Investigative Site
Budapest, Pest County, 1062
Kanghong Investigative Site
Budapest, Pest County, 1076
Kanghong Investigative Site
Budapest, Pest County, 1085
Kanghong Investigative Site
Budapest, Pest County, 1106
Kanghong Investigative Site
Budapest, Pest County, 1133
Kanghong Investigative Site
Budapest, Pest County, 1204
Kanghong Investigative Site
Debrecen, Hajdú-Bihar, 4032
Kanghong Investigative Site
Pécs, Baranya, 7621
Kanghong Investigative Site
Szeged, Csongrád megye, 6720
Kanghong Investigative Site
Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Italy10 sites

Kanghong Investigative Site
Chieti, 66100
Kanghong Investigative Site
Florence, 50134
Kanghong Investigative Site
Genova, 16132
Kanghong Investigative Site
Milan, 20122
Kanghong Investigative Site
Milan, 20132
Kanghong Investigative Site
Milan, 20157
Kanghong Investigative Site
Negrar, 37024
Kanghong Investigative Site
Roma, 00133
Kanghong Investigative Site
Roma, 00198
Kanghong Investigative Site
Udine, 33100

Other trials in Italy

Czechia5 sites

Kanghong Investigative Site
Brno, 625 00
Kanghong Investigative Site
Prague, 100 34
Kanghong Investigative Site
Prague, 10034
Kanghong Investigative Site
Prague, 128 00
Kanghong Investigative Site
Prague, 15000

Other trials in Czechia

Denmark5 sites

Kanghong Investigative Site
Aalborg, 9100
Kanghong Investigative Site
Aarhus N, 8200
Kanghong Investigative Site
Glostrup Municipality, 2600
Kanghong Investigative Site
Roskilde, 4000
Kanghong Investigative Site
Sønderborg, 6400

Other trials in Denmark

Bulgaria4 sites

Kanghong Investigative Site
Plovdiv, 4003
Kanghong Investigative Site
Sofia, 1408
Kanghong Investigative Site
Sofia, 1517
Kanghong Investigative Site
Varna, 9010

Other trials in Bulgaria

China4 sites

Kanghong Investigative Site
Beijing, Beijing Municipality, 100044
Kanghong Investigative Site
Shanghai, Shanghai Municipality, 200031
Kanghong Investigative Site
Shanghai, Shanghai Municipality, 200080
Kanghong Investigative Site
Tianjin, Tianjin Municipality, 300384

Other trials in China

Slovakia4 sites

Kanghong Investigative Site
Bratislava, 82606
Kanghong Investigative Site
Trenčín, 91171
Kanghong Investigative Site
Žilina, 010 08
Kanghong Investigative Site
Žilina, 01207

Other trials in Slovakia

Latvia3 sites

Kanghong Investigative Site
Riga, LV-1002
Kanghong Investigative Site
Riga, LV-1006
Kanghong Investigative Site
Riga, LV-1009

Other trials in Latvia

About this study

Official title: A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)

Read the detailed description

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: Neovascular Age-related Macular Degeneration
Being tested: 0.5 mg Conbercept Intravitreal Injection, 1.0 mg Conbercept Intravitreal Injection, 2.0 mg Aflibercept Intravitreal Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.5 mg Conbercept Intravitreal InjectionBiological
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 Intravitreal InjectionBiological
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.
2.0 mg Aflibercept Intravitreal InjectionBiological
Also called Eylea®
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.

Study groups in NCT03630952
Study group	Role	What they receive
0.5 mg Conbercept	Experimental	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. Receives: Biological: 0.5 mg Conbercept Intravitreal Injection
1.0 mg Conbercept	Experimental	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. Receives: Biological: 1.0 mg Conbercept Intravitreal Injection
Aflibercept	Active comparator	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. Receives: Biological: 2.0 mg Aflibercept Intravitreal Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method
Measured: Baseline to Week 36

Secondary outcomes (9)

Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36
To Assess Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36
Measured: Baseline to Week 36
Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
To Assess Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
Measured: Baseline to Week 36
Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week
To Assess Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week
Measured: Baseline and Week 36
Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
To Assess Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
Measured: Baseline to Week 48
Mean change from baseline in ETDRS BCVA letter score at Week 96
To Assess Mean change from baseline in ETDRS BCVA letter score at Week 96
Measured: Baseline and Week 96
Number of participants with adverse events as measure of safety and tolerability
To Assess Number of participants with adverse events as measure of safety and tolerability
Measured: Baseline to Week 96
Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
To Assess Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
Measured: Baseline to Week 96
Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
To Assess Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
Measured: Baseline to Week 96
Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
To Assess Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
Measured: Baseline to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201819 May 2021

First posted15 Aug 2018
Study start21 Dec 2018
Primary completion10 Sep 2020
Study completion19 May 2021

Why it stopped: desired primary endpoint was not met

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neovascular Age-related Macular DegenerationStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03630952
Sponsor's protocol ID: KHB-1802
Status last verified: Jun 2021
First submitted: 11 Aug 2018
Last updated: 23 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
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A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
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Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
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All Neovascular Age-related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)
ClinicalTrials.gov ID: NCT03630952
Acronym / sponsor ID: KHB-1802
Conditions: Neovascular Age-related Macular Degeneration
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: desired primary endpoint was not met
Enrolment: 1,157 participants (actual)
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Dec 2018 (actual)
Primary completion: 10 Sep 2020 (actual)
Study completion: 19 May 2021 (actual)
First posted: 15 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
0.5 mg Conbercept	Experimental	Biological: 0.5 mg Conbercept Intravitreal InjectionSubjects 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	Experimental	Biological: 1.0 mg Conbercept Intravitreal InjectionSubjects 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	Active comparator	Biological: 2.0 mg Aflibercept Intravitreal InjectionSubjects 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Men and women ≥ 50 years of age at the Screening visit;
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.
Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
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;

Key exclusion criteria (17 listed)

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;
Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
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;
Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;

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
0.5 mg Conbercept Intravitreal InjectionSubjects 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.	Biological	0.5 mg Conbercept
1.0 mg Conbercept Intravitreal InjectionSubjects 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.	Biological	1.0 mg Conbercept
2.0 mg Aflibercept Intravitreal InjectionAlso: Eylea®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.	Biological	Aflibercept

Primary outcome

Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
Time frame: Baseline to Week 36
BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method

9 secondary outcomes

Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36
Time frame: Baseline to Week 36
Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
Time frame: Baseline to Week 36
Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week
Time frame: Baseline and Week 36
Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
Time frame: Baseline to Week 48
Mean change from baseline in ETDRS BCVA letter score at Week 96
Time frame: Baseline and Week 96
Number of participants with adverse events as measure of safety and tolerability
Time frame: Baseline to Week 96
Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
Time frame: Baseline to Week 96
Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
Time frame: Baseline to Week 96
Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
Time frame: Baseline to Week 96

Results and safety

The study was stopped early (reason given: desired primary endpoint was not met). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Individual participant dataSharing planned: No

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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.

Yan Cheng, MD, PhD study director

Chengdu Kanghong Biotechnology Co.,Ltd.

154 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 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: stopped early, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, United Kingdom, Israel, France, Hungary and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: desired primary endpoint was not met). Results are not available in the source record.

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?

Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye (time frame: Baseline to Week 36). 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 NCT03630952.

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 23 Jun 2021.