AzTrials
AzTrials

High Risk Proliferative Diabetic RetinopathyPhase 2NCT01280929

Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy

A Phase 2 study testing Panretinal Photocoagulation (PRP) and Intravitreous injection of ranibizumab in people with High Risk Proliferative Diabetic Retinopathy, run by José Cunha-Vaz at 7 sites in Portugal.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal… 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
54 participants
Where
7 sitesPortugal
Study dates
Sep 2010to Dec 2013
Phase
Phase 2
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) eyes.
  • Best Corrected-Visual Acuity at baseline > 20/320 in the study eye.
  • Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
  • Intraocular pressure < 21 mmHg.
  • Type I, or Type II diabetic subjects as defined by the World Health Organization criteria of either gender, and aged ≥ 18 years.
  • Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
  • Ability to provide written informed consent.
  • Ability to return for all trial visits.

Who cannot join

  • Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
  • Fibrovascular proliferation with retinal traction.
  • Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
  • Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
  • Subjects who have received yttrium-aluminum-garnet laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal/grid photocoagulation, within the previous 6 months.
  • Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
Show all 28Show fewer
  • Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
  • Any intraocular surgery within 6 months before trial enrollment.
  • Previous vitrectomy.
  • HbA1C level >11% or recent signs of uncontrolled diabetes.
  • Any of the following underlying systemic diseases:
  • History or evidence of severe cardiac disease.
  • History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
  • Clinically significant impaired renal function (serum creatinine >2.5 mg/dL or s/p renal transplant or receiving dialysis).
  • Clinically significant impaired hepatic function.
  • Stroke (within 12 months of trial entry).
  • Any major surgical procedure within one month before trial enrollment.
  • Previous radiation to the head in the region of the study eye.
  • Any prior treatment with an investigational agent for diabetic retinopathy or anti-VEGF therapy (including intravitreal, subconjunctival or subtenons corticosteroids) during the past 90 days for any other condition.
  • Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation.
  • Systolic Blood Pressure > 170 (2 different readings) or diastolic Blood Pressure > 100 (2 different readings).
  • Acute ocular or periocular infection.
  • Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery).
  • Use of other investigational drugs at the time of enrollment.
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • 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, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control. Periodic abstinence are not acceptable.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Portugal7 sites

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

    Coimbra, 3000-548

  • Espaço Médico de Coimbra

    Coimbra, 3030-163

  • ALM Oftalmolaser

    Lisbon, 1050-078

  • Instituto de Retina de Lisboa

    Lisbon, 1050-085

  • Instituto de Oftalmologia Dr. Gama Pinto

    Lisbon, 1169-019

  • Instituto CUF

    Porto, 4100-180

  • Hospital de São João

    Porto, 4200-319

Other trials in Portugal

About this study

Official title: Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy (Ranibizumab 0.5 mg Intravitreal Injections) Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP (Monotherapy) in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy

The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.

Read the detailed description

Panretinal photocoagulation can cause regression of retinal neovascularization and reduce the risk of severe vision loss in people with proliferative diabetic retinopathy. However, this destructive treatment may be associated with side effects (such as: pain, transient blurring, loss of peripheral and/or night vision, increased risk of macular edema and central vision loss) and it is not always efficient in the regression of the neovascularization.

Vascular endothelial growth factor (VEGF) has been shown to play a role in retinal neovascularization and retinal vascular leakage related with proliferative diabetic retinopathy and diabetic macular edema. Anti-vascular endothelial growth factor treatments have been hypothesized as an alternative adjunctive treatment for the management of retinal neovascularization and macular edema related with diabetic retinopathy.

There are a few reports of retinal traction detachment in patients with proliferative diabetic retinopathy and fibrovascular proliferation (although it is not frequent). However, from our clinical experience, we think that the risk of detachment only exists when there is in place a fibrovascular proliferation with retinal traction previous to the injection.

We injected ranibizumab prior to surgery in patients with severe proliferative diabetic retinopathy, that were submitted later to a posterior vitrectomy, to reduce neovascularization and minimize the risk of an intraoperatory hemorrhage caused by the manipulation of the fibrovascular membranes. In total, we already injected and submitted to surgery 15 eyes with the above mentioned condition, with excellent results. The results of the first 10 eyes were presented in the congress of the Portuguese Society of Ophthalmology (2008).

Being tested
Panretinal Photocoagulation (PRP), Intravitreous injection of ranibizumab
Keywords
High Risk Proliferative Diabetic Retinopathy, Ranibizumab, Panretinal Photocoagulation

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 NCT01280929
Study groupRoleWhat they receive
Panretinal Photocoagulation (PRP)Active comparatorGroup 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.
Receives: Procedure: Panretinal Photocoagulation (PRP)
RanibizumabExperimentalGroup 2: Intravitreous injections of ranibizumab every 4 weeks at month-0, month-1 and month-2 that can be repeated after month-3.
Receives: Drug: Intravitreous injection of ranibizumab
Ranibizumab + Panretinal Photocoagulation (PRP)ExperimentalGroup 3: Combination treatment of ranibizumab intravitreous injections plus PRP (2 weeks +/- 1 week after injection), at month-0, month-1 and month-2 that can be repeated after month-3.
Receives: Procedure: Panretinal Photocoagulation (PRP); Drug: Intravitreous injection of ranibizumab

What is being measured

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

  1. Regression of neovascularization

    To demonstrate superiority of one of the treatment arms: ranibizumab 0.5 mg monotherapy, panretinal photocoagulation monotherapy or combination therapy (ranibizumab 0.5 mg plus panretinal photocoagulation) over a 12-month treatment period in the regression of neovascularization.

    Measured: 12-month treatment

Secondary outcomes (7)

  1. Changes from baseline in Best-Corrected Visual Acuity

    Best-Corrected Visual Acuity will be assessed during the trial (Baseline, Month 3, Month 6 and Month 12).

    Measured: 12-month treatment

  2. Changes from baseline in macular retinal thickness by Optical Coherent Tomography

    Optical Coherent Tomography will be assessed during the trial (Baseline, Month 3, Month 6 and Month 12).

    Measured: 12-month treatment

  3. Recurrence of neovascularization

    To assess if there is recurrence of neovascularization.

    Measured: 12-month treatment

  4. Number of treatments needed

    To analyse the number treatments given to each subject during the the 12-month treatment.

    Measured: 12-month treatment

  5. Additional focal or grid laser for Diabetic Macular Edema

    To assess the number of patients that received additional focal or grid laser for Diabetic Macular Edema.

    Measured: 12 month treatment

  6. Adverse events

    Drug safety profile.

    Measured: 12-month treatment

  7. Need for vitrectomy due to occurrence of vitreous hemorrhage or retinal detachment relative to the three treatment arms.

    To assess the number of subjects who needed vitrectomy due to occurrence of vitreous hemorrhage or retinal detachment relative to the three treatment arms.

    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 posted21 Jan 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01280929
Sponsor's protocol ID
CRFB002DPT04T
Other IDs
2009-014409-15, 2009
Status last verified
Oct 2015
First submitted
20 Jan 2011
Last updated
8 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Figueira J, Silva R, Henriques J, Caldeira Rosa P, Lains I, Melo P, Goncalves Nunes S, Cunha-Vaz J. Ranibizumab for High-Risk Proliferative Diabetic Retinopathy: An Exploratory Randomized Controlled Trial. Ophthalmologica. 2016;235(1):34-41. doi: 10.1159/000442026. Epub 2015 Dec 3.

    PubMed 26630400

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panretinal Photocoagulation (PRP) and Intravitreous injection of ranibizumab in people with High Risk Proliferative Diabetic Retinopathy, run by José Cunha-Vaz at 7 sites in Portugal.

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 8 inclusion and 28 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 8 Oct 2015. 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 Portugal. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT01280929, 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 8 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in