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High Risk Proliferative Diabetic RetinopathyPhase 2/3PROTEUSNCT01941329

Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy.

A Phase 2/3 study testing Panretinal Photocoagulation (PRP) and Intravitreous injection of ranibizumab in people with High Risk Proliferative Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Panretinal Photocoagulation (PRP) and Intravitreous injection of ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
13 sitesin 4 countries
Study dates
Apr 2014to Oct 2017
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • High-risk proliferative diabetic retinopathy (HR-PDR); Neovascularization in the disc (NVD) ≥ 1/4 disc area (DA) OR Neovascularization elsewhere (NVE) ≥ 1/2 DA; NVE < 1/2 DA + vitreous and/or pre-retinal haemorrhage and/or rubeosis; NVD <1/4 DA + vitreous and/or pre-retinal haemorrhage and/or rubeosis;
  • BCVA at baseline ≥ 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters score (approximate Snellen equivalent 20/320);
  • Type I or Type II diabetic subjects of either gender;
  • Age ≥ 18 years;
  • Ability to provide written informed consent;
  • Ability to return for all clinical trial visits;

Who cannot join

  • Any intraocular surgery within 6 months before trial enrolment, including:
  • Prior scatter (panretinal) or focal/grid photocoagulation; Eyes who have received yttrium aluminum garnet (YAG) laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only);
  • Fibrovascular proliferation with retinal traction;
  • Other cause of retinal NV (retinal vein occlusion, radiation retinopathy or others);
  • Atrophy/scarring/fibrosis/ hard exudates involving the centre of the macula;
  • Significant media opacities or inadequate pupillary dilation, which might interfere with visual acuity, assessment of toxicity or fundus photography;
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  • Any likelihood that the subject will require cataract surgery within the following 1 year;
  • Diabetic macular edema (DME) with central involvement, i.e., central macular thickness (Central Point Thickness) > 300 µm (Stratus OCT) equivalent values measured by spectral domain (SD)-OCT, adjusted according to the SD-OCT machine used;
  • Previous vitrectomy;
  • Intraocular pressure > 21 mmHg;
  • Previous anti-VEGF therapy within the last 3 months;
  • Known serious allergies or history of hypersensitivity to fluorescein used in angiography, or to components of Lucentis® formulation;
  • Acute ocular or periocular infection;
  • Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery); General Exclusion Criteria
  • Systolic BP > 170 mmHg or diastolic BP > 100 mmHg;
  • HbA1C level >11% or recent signs of uncontrolled diabetes;
  • Any of the following underlying systemic diseases:
  • History or evidence of severe cardiac disease, e.g. New York Heart Association (NYHA) Functional Class III or IV, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrhythmia requiring treatment; History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation; Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening; Stroke (within 12 months of trial entry); Any major surgical procedure within one month before trial enrolment;
  • Subject with a condition (such as advanced, severe or unstable disease or its treatment) or is in a situation which may put him/her at significant risk, which may confound the study results or may interfere significantly with the subject's participation in the study;
  • Previous radiation to the head in the region of the study eye;
  • Use of any other investigational drugs within the last 3 months (for DR or other condition);
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases;
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Portugal4 sites

  • Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

    Coimbra, 3000-548

  • Espaço Médico de Coimbra

    Coimbra, 3030-163

  • Instituto de Retina de Lisboa

    Lisbon, 1050-085

  • Serviço de Oftalmologia,Hospital de Vila Franca de Xira

    Vila Franca de Xira, 2600-009

Other trials in Portugal

France3 sites

  • Department of Ophthalmology, University Hospital, CHU Dijon

    Dijon, 21033

  • Department of Ophthalmology, Lariboisière Hospital

    Paris, 75475

  • Centre d'Investigation Clinique - Centre National d'Ophtalmologie des Quinze-Vingts

    Paris, 75571

Other trials in France

Italy3 sites

  • Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael

    Milan, 20132

  • Centre for Clinical Trials, Department of Ophthalmology, University of Padova

    Padova, 35128

  • G.B.Bietti Eye Foundation - IRCCS

    Rome, 00198

Other trials in Italy

United Kingdom3 sites

  • Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

    Frimley, GU16 7UJ

  • Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL53 7PX

  • Laser and Retinal Research Unit, King's Health Partners

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy. (PROTEUS)

This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a 12-month treatment period.

One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of the leading causes of visual impairment in working age in industrialized countries. Longer diabetes duration and poor glycaemic and blood pressure control are strongly associated with Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93 million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic Retinopathy.

Read more

It has been shown that treatment with repeated injections of ranibizumab can improve visual acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete and, therefore, efforts should be done to understand and characterize patients' eyes response to combined treatments.

Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e. Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV injections of ranibizumab since it is expected that anti-vascular endothelial growth factor (VEGF) treatment with ITV injections will increase the rate of success of Panretinal Photocoagulation in regression of neovascularization with improved final visual acuity.

Being tested
Panretinal Photocoagulation (PRP), Intravitreous injection of ranibizumab
Keywords
Diabetes, Proliferative Retinopathy, Ranibizumab, Panretinal Photocoagulation
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • Panretinal Photocoagulation (PRP)Procedure or surgery

  • Intravitreous injection of ranibizumabDrug

Study groups in NCT01941329
Study groupRoleWhat they receive
Ranimizumab + Panretinal photocoagulation (PRP)Experimental3 Intravitreous injections of ranibizumab combined with standard PRP (2 ± 1 weeks after injection), at month-0, month-1 and month-2 that can be repeated after month-3, with always at least 1 month of interval between injections.
Receives: Procedure: Panretinal Photocoagulation (PRP); Drug: Intravitreous injection of ranibizumab
Panretinal photocoagulation (PRP)Active comparatorPanretinal photocoagulation treatment (PRP) between month-0 and month-2, with 1 mandatory laser session in month-0 and more laser sessions as needed until Month-2 to complete the PRP treatment. After completing the PRP treatment, PRP sessions can be repeated from Month-3 to Month-11.
Receives: Procedure: Panretinal Photocoagulation (PRP)

What is being measured

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

  1. Regression of neovascularization

    Defined as any decrease in the area of neovascularization

    Measured: 12-month treatment

Secondary outcomes (7)

  1. Changes in Best Corrected Visual Acuity (BCVA)

    Measured: 12-Month treatment

  2. Time to complete neovascularization regression

    Measured: 12-Month treatment

  3. Recurrence of neovascularization

    Measured: 12-Month treatment

  4. Macular retinal thickness

    Measured: 12-Month treatment

  5. Need of treatment for Diabetic Macular Edema

    Measured: 12-Month treatment

  6. Need of vitrectomy due to the occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of Diabetic Retinopathy.

    Measured: 12-Month treatment

  7. Adverse events related to the treatments

    Measured: 12-Month treatment

Timeline

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

  1. First posted13 Sep 2013 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2016
  4. Study completionOct 2017

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01941329
Sponsor's protocol ID
ECR-RET-2013-05
Acronym
PROTEUS
Status last verified
May 2018
First submitted
10 Sep 2013
Last updated
14 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Panretinal Photocoagulation (PRP) and Intravitreous injection of ranibizumab in people with High Risk Proliferative Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 13 sites in 4 countries.

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 6 inclusion and 23 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: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Portugal, France, Italy, United Kingdom. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Regression of neovascularization (time frame: 12-month treatment). 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 NCT01941329.

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 14 May 2018.

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