Neovascular Age-related Macular DegenerationPhase 3NCT03577899

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)

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 179 sites in 22 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: 179 sitesin 22 countries
Study dates: 25 Sep 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

179 sites in 22 countries.

Country

City, postcode or hospital

179 sites in 22 countries

United States63 sites

Kanghong Investigative Site
‘Aiea, Hawaii, 96701
Kanghong Investigative Site
Abilene, Texas, 79606-1224
Kanghong Investigative Site
Albany, New York, 12206
Kanghong Investigative Site
Beverly Hills, California, 90211-1841
Kanghong Investigator Site
Bloomfield, New Jersey, 07003
Kanghong Investigative Site
Bloomington, Illinois, 61704
Kanghong Investigative Site
Boston, Massachusetts, 02114
Kanghong Investigative Site
Campbell, California, 95008
Kanghong Investigative Site
Chicago, Illinois, 60612
Kanghong Investigative Site
Cincinnati, Ohio, 45242
Kanghong Investigative Site
Cleveland, Ohio, 44122-7344
Kanghong Investigative Site
Cleveland, Ohio, 44195
Kanghong Investigative Site
Detroit, Michigan, 48202
Kanghong Investigative Site
Dublin, Ohio, 43016
Kanghong Investigative Site
Eugene, Oregon, 97401
Kanghong Investigative Site
Fort Myers, Florida, 33907
Kanghong Investigative Site
Fort Myers, Florida, 33912
Kanghong Investigative Site
Fullerton, California, 92835
Kanghong Investigative Site
Glendale, California, 91203
Kanghong Investigative Site
Golden, Colorado, 80401
Kanghong Investigative Site in MD
Hagerstown, Maryland, 21740
Kanghong Investigative Site
Hagerstown, Maryland, 21740
Kanghong Investigative Site
Hauppauge, New York, 11788
Kanghong Investigative Site
Jacksonville, Florida, 32224
Kanghong Investigative Site
Katy, Texas, 77494
Kanghong Investigative Site
La Jolla, California, 92093
Kanghong Investigative Site
Lakeland, Florida, 33805
Kanghong Investigative Site
Lemont, Illinois, 60439-2915
Kanghong Investigative Site
Lynchburg, Virginia, 24502
Kanghong Investigative Site
Morgantown, West Virginia, 26506
Kanghong Investigative Site
Mountain View, California, 94040
Kanghong Investigative Site
Nashville, Tennessee, 37203-5601
Kanghong Investigative Site
Norfolk, Virginia, 23502
Kanghong Investigative Site
Oakland, California, 94609
Kanghong Investigative Site
Ocala, Florida, 34474
Kanghong Investigative Site
Orlando, Florida, 32806
Kanghong Investigative Site
Paducah, Kentucky, 42001
Kanghong Investigative Site
Palm Desert, California, 92211
Kanghong Investigative Site
Palm Desert, California, 92260
Kanghong Investigative Site
Philadelphia, Pennsylvania, 19107
Kanghong Investigative Site
Phoenix, Arizona, 85053
Kanghong Investigative Site
Plantation, Florida, 33324
Kanghong Investigative Site
Rochester, New York, 14620-4655
Kanghong Investigative Site
Sacramento, California, 95825
Kanghong Investigative Site
San Antonio, Texas, 78215
Kanghong Investigative Site
San Antonio, Texas, 78240-1502
Kanghong Investigative Site in TX
San Antonio, Texas, 78240
Kanghong Investigative Site
San Antonio, Texas, 78240
Kanghong Investigative Site
San Antonio, Texas, 78251
Kanghong Investigative Site
Sarasota, Florida, 34239
Kanghong Investigative Site
Silverdale, Washington, 98383
Kanghong Investigator Site
Southlake, Texas, 76902
Kanghong Investigative Site
Spokane, Washington, 99204
Kanghong Investigative Site
St. Petersburg, Florida, 33711
Kanghong Investigative Site
Tampa, Florida, 33617
Kanghong Investigative Site
The Woodlands, Texas, 77384
Kanghong Investigative Site
Tucson, Arizona, 85704
Kanghong Investigative Site
Tyler, Texas, 75701
Kanghong Investigative Site
Walnut Creek, California, 94598
Kanghong Investigative Site
Warrenton, Virginia, 20186
Kanghong Investigative Site
West Mifflin, Pennsylvania, 15122-2474
Kanghong Investigative Site
Wichita, Kansas, 67226-3443
Kanghong Investigative Site
Willow Park, Texas, 76087

Other trials in United States

Spain19 sites

Kanghong Investigative Site
Barcelona, Catalonia, 08907
Kanghong Investigative Site
Barcelona, 08021
Kanghong Investigative Site
Barcelona, 08028
Kanghong Investigative Site
Barcelona, 08035
Kanghong Investigatvie Site
Barcelona, 8024
Kanghong Investigative Site
Bilbao, 48006
Kanghong Investigative Site
Madrid, 28035
Kanghong Investigative Site
Madrid, 28040
Kanghong Investigative Site
Majadahonda, 28222
Kanghong Investigative Site
Oviedo, 33012
Kanghong Investigative Site
Pamplona, 31008
Kanghong Investigative Site
Sant Cugat del Vallès, 08195
Kanghong Investigative Site
Santiago de Compostela, 15706
Kanghong Investigative Site
Seville, Andalusia, 41009
Kanghong Investigative Site
Valencia, 46014
Kanghong Investigative Site
Valencia, 46015
Kanghong Investigative Site
Valladolid, 47012
Kanghong Investigative Site in Zaragoza
Zaragoza, 50009
Kanghong Investigative Site
Zaragoza, 50009

Other trials in Spain

Germany17 sites

Kanghong Investigative Site
Bonn, 53127
Kanghong Investigative Site
Cologne, D-50937
Kanghong Investigative Site
Darmstadt, 64283
Kanghong Investigative Site
Düsseldorf, 40549
Kanghong Investigative Site
Frankfurt am Main, 60590
Kanghong Investigative Site
Freiburg im Breisgau, 79106
Kanghong Investigative Site
Göttingen, 37075
Kanghong Investigative Site
Hanover, 30625
Kanghong Investigative Site
Heidelberg, 69120
Kanghong Investigative Site
Homburg, 66421
Kanghong Investigative Site
Leipzig, 4103
Kanghong Investigative Site
Ludwigshafen, 67063
Kanghong Investigative Site
Mainz, 55131
Kanghong Investigative Site
Marburg, 35043
Kanghong Investigative Site
München, 81675
Kanghong Investigative Site
Münster, 48149
Kanghong Investigative Site
Regensburg, 93053

Other trials in Germany

Australia10 sites

Kanghong Investigative Site
Adelaide, South Australia, 5000
Kanghong Investigative Site
Albury, New South Wales, 2640
Kanghong Investigative Site
Crawley, 6009
Kanghong Investigative Site
Glen Waverley, Victoria, 3150
Kanghong Investigative Site
Liverpool, New South Wales, 2170
Kanghong Investigative Site
Melbourne, Victoria, 3002
Kanghong Investigative Site
Parramatta, New South Wales, 2150
Kanghong Investigative Site
Strathfield, New South Wales, 2135
Kanghong Investigative Site
Sydney, New South Wales, 2000
Kanghong Investigative Site
Sydney, 2000

Other trials in Australia

Canada8 sites

Kanghong Investigative Site
Calgary, Alberta, T2H 0C8
Kanghong Investigative Site
London, Ontario, N6A 4G5
Kanghong Investigative Site
Mississauga, Ontario, L4W 1W9
Kanghong Investigative Site
Montreal, Quebec, H4A 3S5
Kanghong Investigative Site
Montreal, Quebec, H4P 2S4
Kanghong Investigative Site
Sherbrooke, Quebec, J1G 2V4
Kanghong Investigative Site
Toronto, Ontario, M3C 0G9
Kanghong Ivestigative Site
Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

Argentina7 sites

Kanghong Investigative Site
CABA, Buenos Aires, 1120AAN
Kanghong Investigative Site
CABA, Buenos Aires, C1015ABO
Kanghong Investigative Site
CABA, Buenos Aires, C1023AAQ
Kanghong Investigative Site
Córdoba, Córdoba Province, X5000IIT
Kanghong Investigative Site
Córdoba, X5000AAJ
Kanghong Investigative Site
Mendoza, M5500GGK
Kanghong Investigative Site
Rosario, Santa Fe Province, S2000AZH

Other trials in Argentina

Poland7 sites

Kanghong Investigative Site
Gdansk, 80-809
Kanghong Investigative Site
Krakow, Lesser, 31-501
Kanghong Investigative Site
Lodz, 91-134
Kanghong Investigative Site
Lodz, 93-357
Kanghong Investigative Site
Lublin, Woj. Lubelskie 20-079
Kanghong Investigative Site
Olsztyn, 10-424
Kanghong Investigative Site
Wroclaw, 50-556

Other trials in Poland

Austria6 sites

Kanghong Investigative Site
Feldkirch, Hessen, 6800
Kanghong Investigative Site
Klagenfurt, 9020
Kanghong Investigative Site in Linz
Linz, 4021
Kanghong Investigative Site
Linz, 4021
Kanghong Investigative Site
Vienna, 1090
Kanghong Investigative Site
Vienna, 1130

Other trials in Austria

Portugal6 sites

Kanghong Investigative Site
Coimbra, 3000-075
Kanghong Investigative Site
Coimbra, 3000-548
Kanghong Investigative Site
Coimbra, 3030-163
Kanghong Investigative Site
Lisbon, 1050-085
Kanghong Investigative Site
Lisbon, 1649-035
Kanghong Investigative Site
Vila Franca de Xira, Lisbon District, 2600-009

Other trials in Portugal

Switzerland5 sites

Kanghong Investigative Site
Bern, 3010
Kanghong Investigative Site
Bern, 3012
Kanghong Investigative Site
Lausanne, Canton of Vaud, 1000
Kanghong Investigative Site
Zurich, 8063
Kanghong Investigative Site
Zurich, 8091

Other trials in Switzerland

Taiwan5 sites

Kanghong Investigative Site
Changhua, 500
Kanghong Investigative Site
Taipei, 10002
Kanghong Investigative Site
Taipei, 111
Kanghong Investigative Site
Taipei, 11217
Kanghong Investigative Site
Taoyuan, 333

Other trials in Taiwan

Colombia4 sites

Kanghong Investigative Site
Barranquilla, Atlántico, 080001
Kanghong Investigative Site
Bogotá, Bogota D.C., 110121
Kanghong Investigative Site
Cali, 760042
Kanghong Investigative Site
Medellín, 50016

Other trials in Colombia

Peru4 sites

Kanghong Investigative Site
Lima, 0000
Kanghong Investigative Site
Lima, 15036
Kanghong Investigator Site
Lima, 15036
Kanghong Investigative Site
Lima, 15073

Other trials in Peru

Netherlands3 sites

Kanghong Investigative Site
Amsterdam, 1105 AZ
Kanghong Investigative Site
Rotterdam, South Holland, 3011 BH
Kanghong Investigative Site
Tilburg, 5022GC

Other trials in Netherlands

Philippines3 sites

Kanghong Investigative Site
Makati, Manila, 1209
Kanghong Investigative Site
Pasig, Manila, 1600
Kanghong Investigative Site
Quezon City, Manila, 1112

Other trials in Philippines

Belgium2 sites

Kanghong Investigative Site
Laken, 1020
Kanghong Investigative Site
Leuven, B-3000

Other trials in Belgium

Chile2 sites

Kanghong Investigative Site
Santiago, Santiago Metropolitan, 7500000
Kanghong Investigative Site
Santiago, Santiago Metropolitan, 7560994

Other trials in Chile

Hong Kong2 sites

Kanghong Investigative Site in Hong Kong
Hong Kong, 999077
Kanghong Investigative Site
Hong Kong, 999077

Other trials in Hong Kong

Lithuania2 sites

Kanghong Investigative Site
Kaunas, LT-50161
Kanghong Investigative Site
Vilnius, LT-08661

Other trials in Lithuania

Mexico2 sites

Kanghong Investigative Site
Jalisco, Guadalajara, 44689
Kanghong Investigative Site
Jalisco, Guadalajara, 45116

Other trials in Mexico

New Zealand1 site

Kanghong Investigative Site
Auckland, 1149

Other trials in New Zealand

Singapore1 site

Kanghong Investigative Site
Singapore, 119074

Other trials in Singapore

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-1)

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) 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) 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) for a total of 92 weeks of treatment in the study eye.

Study groups in NCT03577899
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) 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) 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) for a total of 92 weeks of 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 36
To assess mean change from baseline in central retinal thickness (µm) by spectral
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 the 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 the 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 the 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.

25 Sep 201819 May 2021

First posted5 Jul 2018
Study start25 Sep 2018
Primary completion25 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: NCT03577899
Sponsor's protocol ID: KHB-1801
Status last verified: Jun 2021
First submitted: 13 Jun 2018
Last updated: 24 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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Active, not recruitingPhase 3
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
Neovascular Age Related Macular Degeneration(nAMD)

All Neovascular Age-related Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 24 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-1)
ClinicalTrials.gov ID: NCT03577899
Acronym / sponsor ID: KHB-1801
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: 25 Sep 2018 (actual)
Primary completion: 25 Sep 2020 (actual)
Study completion: 19 May 2021 (actual)
First posted: 5 Jul 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) 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) 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) for a total of 92 weeks of 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) 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) 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) for a total of 92 weeks of 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 36
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 24 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.

179 sites in 22 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 24 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 179 sites in United States, Spain, Germany, Australia, Canada and 17 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 NCT03577899.

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 24 Jun 2021.