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Proliferative Diabetic RetinopathyNCT02911311

Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

A study testing intravitreal injection of conbercept and PRP in people with Proliferative Diabetic Retinopathy, run by Sun Yat-sen University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Proliferative Diabetic Retinopathy
What is being tested?
intravitreal injection of conbercept and PRP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteChina
Study dates
12 Oct 2019to Dec 2022
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants of either sex aged 18 years or over.
  • Diagnosis of diabetes mellitus (type 1 or 2).
  • Best-corrected visual acuity (BCVA) in the study eye better than or equal to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
  • PDR with no evidence of previous PRP.
  • Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.

Who cannot join

  • a glycated haemoglobin (HbA1c) level of more than 10%;
  • Blood pressure > 180/100 mmHg
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months
  • dialysis or renal transplant
  • Systemic anti-VEGF or pro-VEGF treatment within 6 months prior to randomization
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years
Show all 9Show fewer
  • Traction retinal detachment involving the macula
  • Exam evidence of neovascularization of the angle
  • History of major ocular surgery or anticipated within the next 6 months following randomization

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal neovascularization(NV). The purpose is to assess and compare the efficacy and safety between intravitreal injection of conbercept and PRP.

Read the detailed description

Proliferative diabetic retinopathy (PDR) is a leading cause of vision loss in patients with diabetes mellitus,which of the initial manifestation of PDR is retinal neovascularization at the disc or elsewhere.Panretinal photocoagulation (PRP) has been the standard treatment for PDR since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function including peripheral visual field defects, night vision loss, loss of contrast sensitivity.Recent evidences have indicated that anti-vascular endothelial growth factor(VEGF) treatment can reduce the severity and delay the progression of DR.However,the impact of this treatment on visual function and the effect of anti-VEGF agents on retinal neovascularization compared with PRP remain unclear. It is possible that a long-acting anti-VEGF agent such as conbercept. So we design the study with is a prospective randomized controlled trial about Intravitreal injection of conbercept versus PRP on PDR.Primary outcome is the change in BCVA from screening to 12 months in the study eye measured in the ETDRS letter score at 4 m

Being tested
intravitreal injection of conbercept, PRP
Keywords
conbercept, anti-VEGF agent, panretinal photocoagulation

What participants receive

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

  • intravitreal injection of conberceptDrug

    Also called KH-902 (Chengdu Kanghong Biotech Co., Ltd., Sichuan, China)

    conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration

  • PRPDevice

    panretinal photocoagulation (PPR) is the standard treatment for proliferative diabetic retinopathy (PDR) and is applied to the peripheral retinal tissue to ablate areas of the peripheral retina and thereby reduce retinal oxygen consumption

Study groups in NCT02911311
Study groupRoleWhat they receive
IVC groupExperimentalintravitreal injection of conbercept (IVC) group：all study eyes randomised to receive conbercept will receive an intravitreal injection of conbercept 2 mg/ 0.05 mL at baseline and at 1 and 2 moths. Further treatment since months 3 is determined by the degree of regression of neovascularization (NV) of disc and elsewhere on clinical examination
Receives: Drug: intravitreal injection of conbercept
PRP groupActive comparatorpanretinal photocoagulation (PRP) group:all study eyes randomised to receive PRP will receive an fill-in PRP in 1-2 two weekly sessions as per routine clinical practice with emphasis on targeting retinal nonperfusion areas
Receives: Device: PRP

What is being measured

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

  1. The primary outcome is mean visual acuity change(BCVA)

    Primary outcome is the change in BCVA from screening to 12 moths in the study eye measured in the ETDRS letter score at 4 m

    Measured: 12 months

Secondary outcomes (7)

  1. Visual acuity outcomes in terms of visual gain or loss

    visual gain refers to the proportion of visual improvement ≥ 15 letters at 6-month follow-up, visual loss refers to the proportion of visual reduction ≤ 15 letters at 6-month and 12-month follow-up

    Measured: 6 months and 12 months

  2. the regression patterns of new vessels

    the complete regression proportion of new retinal vessels is evaluated by the fundus photography and fundus fluorescein angiography at 6 months and 12 months

    Measured: 6 months and 12 months

  3. proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy

    proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months

    Measured: 12 months

  4. change of visual field

    change of visual field will be evaluated by the perimeter

    Measured: 12 months

  5. change of retinal function

    change of retinal function measured by electroretinography(ERG)

    Measured: 12 months

  6. change of macular capillary density

    change of macular capillary density measured by Optical coherence tomography angiography

    Measured: 12 months

  7. change of central retinal thickness

    change of central retinal thickness measured by Optical coherence tomography

    Measured: 12 months

Timeline

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

  1. First posted22 Sep 2016 (estimated)
  2. Study start12 Oct 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02911311
Sponsor's protocol ID
CONTINENT
Status last verified
Feb 2021
First submitted
17 Sep 2016
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Writing Committee for the Diabetic Retinopathy Clinical Research Network; Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-2146. doi: 10.1001/jama.2015.15217.

    PubMed 26565927

Questions about this trial

What is this clinical trial studying?

A study testing intravitreal injection of conbercept and PRP in people with Proliferative Diabetic Retinopathy, run by Sun Yat-sen University at 1 site 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 9 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

The primary outcome is mean visual acuity change(BCVA) (time frame: 12 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 NCT02911311, which also lists 1 linked publication.

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 25 Feb 2021.

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