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Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration

Primary Purpose

Age-related Macular Degeneration

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Treat-and-Extend regimen

Pro Re Nata

Conbercept

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Age-related Macular Degeneration, Conbercept, Treat-and-Extend Regimen, Pro Re Nata

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed-consent before any evaluation
Visual impairment due to active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and PCV.
50 years old and older
Chinese
For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at the time point of both screening and baseline.

Exclusion Criteria:

Have Stroke and myocardial infarction within 3 months before screening
Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline.
Uncontrolled glaucoma (under treatment [IOP] ≥ 30 mm Hg or depend on researchers) while screening and baseline
Neovascularization of iris and neovascular glaucoma while screening and baseline
Any causes led to choroidal neovascularization except Wet AMD (including ICNV,central serous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screening and baseline
With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers
Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening
Any medication systemic use toxic to lens, retina and optic nerve,including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
For study eye：Used to accept following treatments for wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib （Macugen®），ranibizumab ,bevacizumab（Avastin®),VEGF-Trap，KH902；b）Anecortave acetate corticosteroids；c）Protein kinase C inhibitors，squalamine，siRNA; d)PDT （Visudyne®）treatment,external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy
Any intraocular surgery(including YAG laser) within 3 months before baseline or predicated within 6 months after baseline
Intraocular or periocular treatment of corticosteroids within 3 months before baseline
For follow eye:Any anti-angiogenesis treatment(including anti-VEGF,like Lucentis,Avastin® and KH902 ) within 3 months before baseline

Sites / Locations

Central Theater Command General Hospital
Eye & Ent Hospital of Fudan University
Shanghai First People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conbercept 0.5mg Treat-and-Extend regimen

Conbercept 0.5mg Pro Re Nata

Arm Description

Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and Treat-and-Extend Regimen of the same dose guided by BCVA stabilization and optical coherence tomography (OCT) in the extension treatment period. Intervention: Drug: Conbercept

Monthly intravitreal injections of Conbercept 0.5mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period. Intervention: Drug: Conbercept

Outcomes

Primary Outcome Measures

Mean Snellen BCVA at every visit or treatment

Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

Secondary Outcome Measures

Number of participants with treatment-related adverse events

Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of Treat-and-Extend regimen of Conbercept

Mean number of injections after the initial three loading dose monthly injections

Compare of mean number of injections after the initial three loading dose monthly injections between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

mean central macular thickness at every visit or treatment by OCT

Compare of mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

Full Information

NCT ID

NCT02802657

First Posted

June 5, 2016

Last Updated

May 17, 2020

Sponsor

Xiaodong Sun

Collaborators

Eye & ENT Hospital of Fudan University, Shanghai Zhongshan Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, The General Hospital of Central Theater Command

1. Study Identification

Unique Protocol Identification Number

NCT02802657

Brief Title

Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration

Official Title

A Multicenter Study Comparing Efficacy and Safety of " Treat-and-Extend" Regimen Versus "Pro Re Nata" Regimen of Conbercept in Neovascular Age-related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (Actual)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaodong Sun

Collaborators

Eye & ENT Hospital of Fudan University, Shanghai Zhongshan Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, The General Hospital of Central Theater Command

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study will evaluate the efficacy and safety of two different regimens of Conbercept (Treat-and-Extend (T&E) Regimen vs. Pro Re Nata (PRN)) in patients with wet AMD. This study is to provide long-term safety data in the treatment of patients with wet Age-related Macular Degeneration (AMD).

Detailed Description

Participants with wAMD were randomized and received a T&E or PRN regimen for 24 months. Mean Snellen BCVA and mean central macular thickness by OCT were examined at each visit. Any treatment-related adverse events, such as endophthalmitis, and systemic adverse events, such as stroke, were evaluated during the research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

Age-related Macular Degeneration, Conbercept, Treat-and-Extend Regimen, Pro Re Nata

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conbercept 0.5mg Treat-and-Extend regimen

Arm Type

Experimental

Arm Description

Arm Title

Conbercept 0.5mg Pro Re Nata

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Treat-and-Extend regimen

Other Intervention Name(s)

T&E

Intervention Description

For the T&E regimen,investigators recorded patients' data after retreatment by 3 monthly intravitreal injections of Conbercept. Patients were examined 6 weeks after the third injection, with ETDRS visual acuity testing, fundus ophthalmoscopy and photography, and OCT, and treated on the same day. The interval between treatments was extended by 2-week (12-week was a maximum) provided that OCT and fundus examination did not show either exudative manifestations or new macular hemorrhage or active CNV or reduced by 2 weeks (4-week was minimum) in case of such manifestations or hemorrhage. The persistence of pigment epithelium detachment was not considered a condition that justified shortening the interval between injections.

Intervention Type

Procedure

Intervention Name(s)

Pro Re Nata

Other Intervention Name(s)

PRN

Intervention Description

For the PRN group, investigators recorded patients'data after retreatment by 3 monthly intravitreal injections of Conbercept.Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four to five weeks after the third and last injection, all patients in the PRN group underwent an examination, including ETDRS visual acuity, fundus photography,and OCT. In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of >5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.

Intervention Type

Drug

Intervention Name(s)

Conbercept

Primary Outcome Measure Information:

Title

Mean Snellen BCVA at every visit or treatment

Description

Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events

Description

Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of Treat-and-Extend regimen of Conbercept

Time Frame

24 months

Title

Mean number of injections after the initial three loading dose monthly injections

Description

Compare of mean number of injections after the initial three loading dose monthly injections between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

Time Frame

21 months

Title

mean central macular thickness at every visit or treatment by OCT

Description

Compare of mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of Treat-and-Extend regimen of Conbercept.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed-consent before any evaluation Visual impairment due to active CNV,including predominantly classic CNV,minimally classic CNV,occult CNV with no classic component and PCV. 50 years old and older Chinese For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at the time point of both screening and baseline. Exclusion Criteria: Have Stroke and myocardial infarction within 3 months before screening Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline. Uncontrolled glaucoma (under treatment [IOP] ≥ 30 mm Hg or depend on researchers) while screening and baseline Neovascularization of iris and neovascular glaucoma while screening and baseline Any causes led to choroidal neovascularization except Wet AMD (including ICNV,central serous chorioretinopathy,ocular histoplazmoza and pathologic myopia) while screening and baseline With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening Any medication systemic use toxic to lens, retina and optic nerve,including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol For study eye：Used to accept following treatments for wet AMD within 3 months or accept following treatments more than three times before baseline: a)Anti-angiogenesis drugs(pegaptanib （Macugen®），ranibizumab ,bevacizumab（Avastin®),VEGF-Trap，KH902；b）Anecortave acetate corticosteroids；c）Protein kinase C inhibitors，squalamine，siRNA; d)PDT （Visudyne®）treatment,external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy Any intraocular surgery(including YAG laser) within 3 months before baseline or predicated within 6 months after baseline Intraocular or periocular treatment of corticosteroids within 3 months before baseline For follow eye:Any anti-angiogenesis treatment(including anti-VEGF,like Lucentis,Avastin® and KH902 ) within 3 months before baseline

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaodong Sun

Organizational Affiliation

Shanghai General Hospital, Shanghai Jiao Tong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Theater Command General Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430070

Country

China

Facility Name

Eye & Ent Hospital of Fudan University

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Shanghai First People's Hospital

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Shanghai Tongji Hospital, Tongji University School of Medicine

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Shanghai Zhongshan Hospital

City

Shanghai

ZIP/Postal Code

200080

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration

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