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Diabetic RetinopathyPhase 3NCT03452657

Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)

A Phase 3 study testing Ranibizumab and No drug in people with Diabetic Retinopathy and Ranibizumab, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 7 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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to determine the efficacy and safety of intravitreous ranibizumab treatment versus sham injections for prevention of high-risk DR. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Diabetic Retinopathy, Ranibizumab
What is being tested?
Ranibizumab and No drug
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
7 sitesChina
Study dates
Apr 2018to Jun 2020
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years;
  • Diagnosis of diabetes mellitus (type 1 or type 2);
  • The fundus color photography was graded by Reading Center as grade 47-53;
  • Patients have not received Pan Retinal Photocoagulation (PRP: laser spots on fundus outside hemal arch are less than 100);
  • HbA1C≤ 10%;
  • Media clarity and pupillary dilation sufficient to obtain adequate fundus examinations;
  • No central subfield macular edema.

Who cannot join

  • Ocular infection, including conjunctivitis, chalazion, or substantial blepharitis;
  • Proliferative diabetic retinopathy;
  • History of prior vitreous hemorrhage within 2 months;
  • An ocular condition is presented (other than DR), (e.g., retinal vein or artery occlusion, CNV, retinal detachment, macular hole, vitreomacular traction, etc.);
  • Evidence of iris neovascularization;
  • Evidence of uncontrolled glaucoma( Intraocular pressure >25 mmHg with glaucoma medication) or history of anti-glaucoma surgery;
Show all 48Show fewer
  • Server cataract that influences judgment or needs cataract surgery in 6 months;
  • Aphakia;
  • Received other ocular treatment:
  • History of intravitreal injection of corticosteroid within 3 months, or peribulbar injection of corticosteroid within 1 month;
  • History of vitreous surgery;
  • History of PRP ≥ 2 times or within 6 months in the study eye;
  • History of focal laser treatment within 3 months or laser treatment involving fovea ≥ 2 times in the past in the study eye;
  • History of anti-VEGF treatment within 6 months in the study eye or history of anti-VEGF treatment within 3 months in the non-study eye;
  • History of any intraocular surgery within 3 months;
  • History of macular surgery within 3 months;
  • Have any following condition of systemic diseases:
  • Unsatisfactory blood glucose control within 3 months (defined as turn oral antidiabetic drugs into insulin therapy/insulin pump treatment or daily insulin injection times doubled);
  • Impaired renal function (Crea: 2 times higher than the upper limit of the normal laboratory center) or liver dysfunction (ALT, AST: 2 times higher than the upper limit of the normal laboratory center );
  • Poor blood pressure control (defined as systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg under antihypertensive therapy);
  • Any systemic infection that requires oral, intramuscular or intravenous administration ;
  • Stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure occurred within 6 months before the screening;
  • Coagulation dysfunction (prothrombin time ≥ normal upper limit of 3 seconds, activated partial thromboplastin time ≥ normal upper limit of 10 seconds);
  • Drugs that are toxic to the lens, retina, or optic nerve are being used or may be required during the study (such as deferoxamine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazine or ethambutol, etc.);
  • Have a diagnosis of systemic immune diseases (such as ankylosing spondylitis, systemic lupus erythematosus, etc.) or any uncontrollable clinical problems (such as AIDS, malignancy, active hepatitis, severe mental, neurological, cardiovascular, Respiratory and other diseases, etc.);
  • Known allergy to fluorescein dye, or protein products for treatment or diagnosis, or allergies to more than two drugs and / or nonpharmacological factors, or is suffering from allergic diseases;
  • Other:
  • No use of effective contraception; Note: The following conditions are not excluded. I. Amenorrhea 12 months under natural circumstances, or natural amenorrhea for 6 months and serum follicle-stimulating hormone levels <40 mIU / ml; Ii. Bilateral ovariectomy with or without hysterectomy after 6 weeks; Iii. Use of one or more of the following acceptable contraceptive methods: sterilization (male with bilateral vasectomy, resection) , hormone contraceptive (implantable, patch-type, oral) , O IUD, or double barrier method; Iv. Reliable contraceptive measures used throughout the whole study period and adherence to the 30 days of discontinuation of the study drug (unacceptable contraceptive methods: regular abstinence - calendar, ovulation, body temperature, post-ovulation, Row fine);
  • Pregnant (pregnancy in this test is defined as urine pregnancy test positive) or lactating women;
  • Within 3 months (if the test drug has a long half-life and five half-life periods > 3 months, the time is 5 half-life periods) before screening, participated clinical trials of any drug (not including vitamins and minerals);
  • Those that researchers believe need to be excluded.
  • Exit Criteria:
  • During the clinical trial, patients may withdraw from the trial at any time for their own consideration or at the request of the investigator. For each subject who withdrawn from the trial, the investigator must detail the exit date, reasons, and other information in the case report form and original documents.
  • Subjects must withdraw from the study if:
  • Withdrawal of informed consent;
  • Participating in other clinical trials of new drugs during the trial;
  • Pregnancy during the trial;
  • Occurrence of ocular serious adverse events;
  • For safety, the researcher consider that the subject should withdraw from the trial.
  • Subjects may withdraw from the study early because of the following conditions:
  • Lost to follow-up;
  • Compliance issues;
  • Delay of injection more than 30 days for any reason;
  • Retinal laser photocoagulation is required during the trial;
  • Researchers consider that the treatments in this study (including remedial treatment) are no longer suitable for DME therapy in subjects;
  • Occurrence of adverse events or serious adverse events (subjects that need hospitalization or prolongation of hospital stay due to adverse events, without affecting the safety and efficacy evaluation, may not exit);
  • Use of prohibited drugs during the study;
  • Deviation from the research protocol.

Trial locations and contacts

7 sites in 1 country.

Kun Liu contact

+86 18917989522

drkunliu@sjtu.edu.cn

7 sites in 1 country

China7 sites

  • Eye and ENT hospital of Fudan University

    Shanghai

    Chunhui Jiang, +86 13801843682

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

    Lin Liu, +86 18918358758

  • Shanghai ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

    Chaoyang Wang, +86 15921108602

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

    Shanghai

    Qiang Wu, +86 18930177422

  • Shanghai Tenth People's Hospital of Tongji University

    Shanghai

    Fang Wang, +86 18917683335

  • Shanghai Tongji Hospital of Tongji University

    Shanghai

    Ao Rong, +86 13818295715

  • Xinhua Hospital Afflilliated to Shanghai Jiaotong University School of Medicine

    Shanghai

    Peiquan Zhao, +86 13311620396

Other trials in China

About this study

The purpose of this study is to determine the efficacy and safety of intravitreous ranibizumab treatment versus sham injections for prevention of high-risk DR.

Read the detailed description

This study is a randomized, double-blind, multi-center, sham-controlled clinical trial. In this trial, 118 subjects will be enrolled. Subjects with signed informed consent are screened and assigned randomly (1:1) to one of the following parallel groups: Group A-Intravitreous 0.5 mg ranibizumab injections and Group B-sham injections. All participants have visits at 0 month, 1 month, and 2 months, followed by visits every 3 months thereafter through 1 year. The main efficacy and safety outcomes assessment will be finished at the end of 12 months.

Being tested
Ranibizumab, No drug
Medical subject headings
Diabetic Retinopathy

What participants receive

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

  • RanibizumabDrug

    Also called Lucentis

    Participants in arm Ranibizumab will receive ranibizumab injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year

  • No drugProcedure or surgery

    Participants in arm Sham-injection will receive sham injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year.

Study groups in NCT03452657
Study groupRoleWhat they receive
RanibizumabExperimentalParticipants received 0.5mg intravitreal ranibizumab injection
Receives: Drug: Ranibizumab
Sham-injectionSham comparatorNo drug involved in the sham procedure; patient's eye is anesthetized and a syringe without needle gently pressed on the conjunctival surface to simulate the force of an actual injection
Receives: Procedure: No drug

What is being measured

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

  1. Proportion of eyes with a ≥ 2-step improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score

    Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)

    Measured: 1 year

Secondary outcomes (3)

  1. Change from baseline in CRT (central retinal thickness)

    Assessed on Optical Coherence Tomography (OCT)

    Measured: 1 year

  2. Mean change from baseline in best-corrected visual acuity (BCVA)

    Visual function of the study eye was assessed using the ETDRS protocol.

    Measured: 1 year

  3. Proportion of eyes that meet the protocol-defined failure criteria

    Failure criteria: Evidence of progression to PDR:

    1. Retinal neovascularization
    2. Iris neovascularization
    3. PDR related clinical manifestations: vitreous hemorrhage, tractive retinal detachment, etc..

    Patients who meet failure criteria will receive salvage therapy: PRP treatment.

    Measured: 1 year

Timeline

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

  1. First posted2 Mar 2018
  2. Study startApr 2018 (estimated)
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452657
Sponsor's protocol ID
DLY201612
Status last verified
Mar 2018
First submitted
22 Feb 2018
Last updated
2 Mar 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab and No drug in people with Diabetic Retinopathy and Ranibizumab, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 7 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 7 inclusion and 48 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 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kun Liu (+86 18917989522, drkunliu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of eyes with a ≥ 2-step improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score (time frame: 1 year). 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 NCT03452657.

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 2 Mar 2018.

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