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Age-related Macular DegenerationPhase 4NCT02802657

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

A Phase 4 study testing Treat-and-Extend regimen, Pro Re Nata and Conbercept in people with Age-related Macular Degeneration, run by Xiaodong Sun at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
Treat-and-Extend regimen, Pro Re Nata and Conbercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
5 sitesChina
Study dates
Sep 2016to Sep 2020
Phase
Phase 4
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

  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Eye & Ent Hospital of Fudan University

    Shanghai, 200080

  • Shanghai First People's Hospital

    Shanghai, 200080

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    Shanghai, 200080

  • Shanghai Zhongshan Hospital

    Shanghai, 200080

  • Central Theater Command General Hospital

    Wuhan, Hubei, 430070

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Treat-and-Extend regimen, Pro Re Nata, Conbercept
Keywords
Age-related Macular Degeneration, Conbercept, Treat-and-Extend Regimen, Pro Re Nata
Medical subject headings
Macular Degeneration

What participants receive

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

  • Treat-and-Extend regimenProcedure or surgery

    Also called T&E

    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.

  • Pro Re NataProcedure or surgery

    Also called PRN

    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.

  • ConberceptDrug

Study groups in NCT02802657
Study groupRoleWhat they receive
Conbercept 0.5mg Treat-and-Extend regimenExperimentalMonthly 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
Receives: Procedure: Treat-and-Extend regimen; Drug: Conbercept
Conbercept 0.5mg Pro Re NataActive comparatorMonthly 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
Receives: Procedure: Pro Re Nata; Drug: Conbercept

What is being measured

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

  1. 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.

    Measured: 24 months

Secondary outcomes (3)

  1. 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

    Measured: 24 months

  2. 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.

    Measured: 21 months

  3. 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.

    Measured: 24 months

Timeline

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

  1. First posted16 Jun 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionSep 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02802657
Sponsor's protocol ID
15216713049
Status last verified
May 2020
First submitted
5 Jun 2016
Last updated
19 May 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Rush RB, Simunovic MP, Vandiver L, Aragon AV 2nd, Ysasaga JE. Treat-and-extend bevacizumab for neovascular age-related macular degeneration: the importance of baseline characteristics. Retina. 2014 May;34(5):846-52. doi: 10.1097/IAE.0000000000000033.

    PubMed 24240560

  • Chen YN, Powell AM, Mao A, Sheidow TG. RETROSPECTIVE REVIEW OF LUCENTIS "TREAT AND EXTEND" PATTERNS AND OUTCOMES IN AGE-RELATED MACULAR DEGENERATION. Retina. 2016 Feb;36(2):272-8. doi: 10.1097/IAE.0000000000000691.

    PubMed 26200511

  • Wykoff CC, Croft DE, Brown DM, Wang R, Payne JF, Clark L, Abdelfattah NS, Sadda SR; TREX-AMD Study Group. Prospective Trial of Treat-and-Extend versus Monthly Dosing for Neovascular Age-Related Macular Degeneration: TREX-AMD 1-Year Results. Ophthalmology. 2015 Dec;122(12):2514-22. doi: 10.1016/j.ophtha.2015.08.009. Epub 2015 Sep 29.

    PubMed 26391465

  • Spaide R. Ranibizumab according to need: a treatment for age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):679-80. doi: 10.1016/j.ajo.2007.02.024. No abstract available.

    PubMed 17386275

  • Mrejen S, Jung JJ, Chen C, Patel SN, Gallego-Pinazo R, Yannuzzi N, Xu L, Marsiglia M, Boddu S, Freund KB. Long-Term Visual Outcomes for a Treat and Extend Anti-Vascular Endothelial Growth Factor Regimen in Eyes with Neovascular Age-Related Macular Degeneration. J Clin Med. 2015 Jul 8;4(7):1380-402. doi: 10.3390/jcm4071380.

    PubMed 26239682

  • Berg K, Hadzalic E, Gjertsen I, Forsaa V, Berger LH, Kinge B, Henschien H, Fossen K, Markovic S, Pedersen TR, Sandvik L, Bragadottir R. Ranibizumab or Bevacizumab for Neovascular Age-Related Macular Degeneration According to the Lucentis Compared to Avastin Study Treat-and-Extend Protocol: Two-Year Results. Ophthalmology. 2016 Jan;123(1):51-9. doi: 10.1016/j.ophtha.2015.09.018. Epub 2015 Oct 21.

    PubMed 26477842

  • Oubraham H, Cohen SY, Samimi S, Marotte D, Bouzaher I, Bonicel P, Fajnkuchen F, Tadayoni R. Inject and extend dosing versus dosing as needed: a comparative retrospective study of ranibizumab in exudative age-related macular degeneration. Retina. 2011 Jan;31(1):26-30. doi: 10.1097/IAE.0b013e3181de5609.

    PubMed 20890246

  • Chin-Yee D, Eck T, Fowler S, Hardi A, Apte RS. A systematic review of as needed versus treat and extend ranibizumab or bevacizumab treatment regimens for neovascular age-related macular degeneration. Br J Ophthalmol. 2016 Jul;100(7):914-917. doi: 10.1136/bjophthalmol-2015-306987. Epub 2015 Oct 29.

    PubMed 26516125

  • Houston SK 3rd, Rayess N, Cohen MN, Ho AC, Regillo CD. INFLUENCE OF VITREOMACULAR INTERFACE ON ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY USING TREAT AND EXTEND TREATMENT PROTOCOL FOR AGE-RELATED MACULAR DEGENERATION (VINTREX). Retina. 2015 Sep;35(9):1757-64. doi: 10.1097/IAE.0000000000000663.

    PubMed 26110596

  • Gupta OP, Shienbaum G, Patel AH, Fecarotta C, Kaiser RS, Regillo CD. A treat and extend regimen using ranibizumab for neovascular age-related macular degeneration clinical and economic impact. Ophthalmology. 2010 Nov;117(11):2134-40. doi: 10.1016/j.ophtha.2010.02.032. Epub 2010 Jul 1.

    PubMed 20591490

  • Abedi F, Wickremasinghe S, Islam AF, Inglis KM, Guymer RH. Anti-VEGF treatment in neovascular age-related macular degeneration: a treat-and-extend protocol over 2 years. Retina. 2014 Aug;34(8):1531-8. doi: 10.1097/IAE.0000000000000134.

    PubMed 24637667

  • Homer N, Grewal DS, Mirza RG, Lyon AT, Gill MK. Transitioning to intravitreal aflibercept following a previous treat-and-extend dosing regimen in neovascular age-related macular degeneration: 24-month results. Eye (Lond). 2015 Sep;29(9):1152-5. doi: 10.1038/eye.2015.87. Epub 2015 May 29.

    PubMed 26021870

  • Li X, Xu G, Wang Y, Xu X, Liu X, Tang S, Zhang F, Zhang J, Tang L, Wu Q, Luo D, Ke X; AURORA Study Group. Safety and efficacy of conbercept in neovascular age-related macular degeneration: results from a 12-month randomized phase 2 study: AURORA study. Ophthalmology. 2014 Sep;121(9):1740-7. doi: 10.1016/j.ophtha.2014.03.026. Epub 2014 May 1.

    PubMed 24793528

  • Zhang M, Zhang J, Yan M, Luo D, Zhu W, Kaiser PK, Yu DC; KH902 Phase 1 Study Group. A phase 1 study of KH902, a vascular endothelial growth factor receptor decoy, for exudative age-related macular degeneration. Ophthalmology. 2011 Apr;118(4):672-8. doi: 10.1016/j.ophtha.2010.08.008. Epub 2010 Dec 13.

    PubMed 21146224

  • Jia H, Lu B, Yuan Y, Yuan F, Li L, Song Y, Rong A, Zhou M, Wang F, Sun X. A Randomized, Controlled Trial of Treat-and-Extend vs. Pro Re Nata Regimen for Neovascular Age-Related Macular Degeneration. Front Med (Lausanne). 2022 Jun 20;9:852519. doi: 10.3389/fmed.2022.852519. eCollection 2022.

    PubMed 35795633

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treat-and-Extend regimen, Pro Re Nata and Conbercept in people with Age-related Macular Degeneration, run by Xiaodong Sun at 5 sites in China.

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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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 Snellen BCVA at every visit or treatment (time frame: 24 months). 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 NCT02802657, which also lists 15 linked publications.

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 19 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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