PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy

December 6, 2013 updated by: Rafael de Montier P. Barroso, MD, University of Sao Paulo

Three Arm, Prospective, Single-blind, Randomized Study Comparing Ranibizumab Plus Green Diode Laser Versus Ranibizumab Plus Pattern Scan Laser (Pascal) Versus Ranibizumab (Monotherapy) for Proliferative Diabetic Retinopathy.

Objectives:

Primary objective:

To evaluate the effects on retinal morphophysiology of full scatter single target panretinal photocoagulation (PRP) versus full scatter multiple target panretinal photocoagulation (both combined with intravitreous injections of ranibizumab) versus intravitreous ranibizumab (IVR) alone in patients with proliferative diabetic retinopathy (PDR).

Primary outcome:

The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2, from baseline to week 48.

Secondary objectives:

  • To assess the mean changes in best corrected visual acuity (BCVA), the mean changes in central subfield foveal thickness (CSFT), the mean changes in wave B amplitude and oscillatory potentials on a full-field electroretinogram (ERG), and the mean changes on the peripheral visual field by static perimetry (30:2 strategy), from baseline to week 48.
  • To assess the incidence of adverse events during the study.

Strategic goal:

In the era of anti-VEGF treatment for retinal neovascularization 1, 2, 3, 4 , it is time to determine what would be the best association of PRP + anti-VEGF for proliferative diabetic retinopathy (PDR), or still, if just intravitreal anti-VEGF treatment would be even better regarding morphologic (new vessels area and CSFT) and functional parameters (BCVA, ERG response and visual field).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Photocoagulation (thermal laser) was the first modality to be described for the treatment of PDR. Different types of laser such as xenon, krypton, argon, red diode and green diode can be used for this treatment. The Early Treatment Diabetic Retinopathy Study (ETDRS) showed the benefit of early treatment of PDR and of macular edema with laser photocoagulation.

However, several studies have reported loss of visual field after laser photocoagulation of the bilateral full-scatter type (PRP) due to the expansion of the thermal injury, possibly even compromising the ability to drive automotive vehicles according to the standards of the transit authorities of some countries. Thus, this implies a greater impact on the quality of life of the patient, especially if he is a young diabetic.6

The objective of new laser photocoagulation technologies is to provide a treatment that will permit the development of a regenerative response of photoreceptors and of the retinal pigment epithelium (RPE) with the minimum loss of photoreceptors and the minimum cicatricial expansion of the thermal injury on the targeted RPE.7

The PASCAL photocoagulator (OptiMedica, Santa Clara, California) (a standard scanning laser) was introduced in 2005 for retinal photocoagulation. The device functions as if it partially automated the procedure by means of a shorter laser pulse (short pulse strategy) combined with multiple simultaneous firings in a pattern, performing the procedure within a shorter period of time and with less damage to the outer retina or the RPE, in addition to providing better patient comfort.8

Regarding combined therapy, the combination of intravitreous injection of ranibizumab with PRP (ETDRS) proved to be more promising in terms of improved visual acuity, stability of macular thickness and a greater regression rate of neovessel areas than the use of PRP alone (ETDRS) in patients with high risk PDR.1

Thus, in the present study we would like to determine which would be the best therapeutic combination of laser and an anti-VEGF drug for our patients, or whether treatment with an anti-VEGF drug alone would be better in terms of the anatomical and functional parameters proposed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil
        • Retina and Vitreous service of the University Hospital, Faculty of Medicine of Ribeirão Preto-USP (HCFMRP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diabetic patients older than 18 years
  2. Presence of PDR (presence of retinal neovascularization, defined as active neovessels (fine retinal vessels with saccular dilatations or extremities covered with blood or associated with recurrent vitreous hemorrhage) with visual acuity better than 20/800 and with no previous laser treatment
  3. Giving written informed consent.

Exclusion Criteria:

  1. Presence of advanced PDR, i.e.: vitreous hemorrhage that would prevent documentation of the eye fundus or adequate retinal photocoagulation, or presence of traction retinal detachment
  2. Presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc
  3. Any abnormality of the vitreoretinal interface in the macular region for which the investigator would consider vitrectomy via pars plana to be necessary
  4. Intravitreous injection of corticosteroids or of other antiangiogenic drugs 6 months before the evaluation for entry into the study
  5. Inability to fixate and to conclude the automated static perimetry exam
  6. Cataract surgery within the last three months
  7. Posterior vitrectomy with scleral introflexion at any time
  8. Acute ocular infection
  9. Allerghy to fluorescein
  10. Medical or psychological conditions that would prevent the patient from giving informed consent and concluding the study
  11. Significant uncontrolled diseases which, in the opinion of the investigator, would exclude the patient from the study
  12. Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels >2.0 mg/dl
  13. Untreated diabetes mellitus
  14. Severe (blood pressure systolic > 160 mmHg or diastolic > 100 mmHg) AND untreated hypertension
  15. Inability to comply with study or follow-up procedures.
  16. Impaired or limited legal capacity
  17. Participation in another clinical study in the last 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SS-PRP arm
panfotocoagulation (PRP) single shoot (ETDRS) + 0,05ml intravitreal injection anti-VEGF (ranibizumabe)
Drug: Intravitreal Ranibizumabe
Intravitreal injection 0,05ml Ranibizumabe
Drug: panfotocoagulation (PRP) single shoot (ETDRS)
Experimental: MS-PRP arm
Multiple shoot panfotocoagulation (PASCAL) plus IVR
Drug: Intravitreal Ranibizumabe
Intravitreal injection 0,05ml Ranibizumabe
Drug: panfotocoagulation (PASCAL)
Other: IVR arm
only IVR (intravitreal Ranibizumabe)
Drug: Intravitreal Ranibizumabe
Intravitreal injection 0,05ml Ranibizumabe

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fluorescein angiography leakage area
Time Frame: from baseline to week 48.
The primary endpoint for this study is the mean change in the total area of active retinal neovessels, as measured by fluorescein angiography leakage area, in mm2.
from baseline to week 48.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRALA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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