Laser (Selective Retina Therapy) and Drug Combined Intervention in Clinically Significant Diabetic Macular Edema

November 28, 2018 updated by: LUTRONIC Corporation

A Prospective, Single-Center, Randomized, Double Blind, Double Arm, Comparative Clinical Trial to Compare the Safety and Preliminary Efficacy Between Ranibizumab Monotherapy and Ranibizumab Combined With R:GEN (Selective Retina Therapy) in Clinically Significant Diabetic Macular Edema (a Pilot Study)

The objective of this clinical trial is to compare and evaluate the safety and efficacy of Ranibizumab (Lucentis®; Novartis AG, Basel, Switzerland) monotherapy and Ranibizumab combined with R:GEN (Selective Retina Therapy) in patients with clinically significant diabetic macular edema.

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

This is a prospective, single-center, randomized, double blind, double arm, comparative clinical trial to compare the safety and efficacy between ranibizumab monotherapy and ranibizumab combined with Selective Retina Therapy (SRT) in clinically significant diabetic macular edema (a pilot study).

Screening visit should be conducted within 30 days before the baseline visit. After assigning a screening number (SN) to the participants who voluntarily agreed in writing to participate in the clinical trial, conduct a screening test to determine whether the subject meet the inclusion/ exclusion criteria.

Proceed with the clinical trial with the appropriate subjects determined based on the inclusion/exclusion criteria. Random allocation numbers (AN) are assigned.

Participants are randomly assigned to study group or control group. Combination therapy of SRT and ranibizumab is performed in the study group and sham SRT and ranibizumab monotherapy is performed in the control group. (Sham) SRT and ranibizumab (re-performance) is performed by the institution's investigator other than the independent evaluator.

In the study group and control group, after the completion of 5 ranibizumab injections during the loading period, if the independent evaluator judges the following criteria apply based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) findings at each visit from the 5th month, ranibizumab is re-administered by an investigator other than the independent evaluator, within 14 days of the visit or on the day of visit; If the independent evaluator judges that CMT on the OCT is equal to or greater than the baseline; or if the independent evaluator judges that BCVA is equal to or worse than the baseline.

The study group and the control group visit the hospital at the time of (Sham) SRT and ranibizumab performance from the baseline until 5 months and make a visit every month from 6 months to 12 months.

From 13 months ± 14 days after the baseline, the schedule of visits can be determined at intervals of 1 month ± 14 days to 3 months ± 14 days at the discretion of the investigator other than the independent evaluator. However, at the time of 24 months, both the study group and the control group should visit the hospital for efficacy and safety evaluation.

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.
12

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Hallym University Kangnam Sacred Heart Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults older than 19 years of age
  2. Patients with Type-I or Type-II diabetes

  3. Patients diagnosed with Clinically Significant Diabetic macular edema (CSME) based on the criteria of Early Treatment Diabetic Retinopathy Study (ETDRS).

    • If thickened retina is within or lies on the circle with a radius of 500µm from the center of the fovea, or
    • If the hard exudate is within or lies on the circle with a radius of 500 ㎛ and if the retina adjacent to it is thickened, or
    • If there is a thickened retina larger than 1 disc area and if a part of it is over the circle with a radius of 1 disc diameter from the center of the macula.
  4. Central Macular Thickness (CMT) of study eye is more than 300㎛ on OCT
  5. Patients with BCVA of the study eye between 20/320 and 20/25.
  6. Patients who have agreed to participate in this study and signed the consent form, and patients whose legally acceptable representative signed the consent form

Exclusion Criteria:

  1. Patients with Ischemic DME that showed rupture in the Foveal Avascular Zone due to the obstruction of more than 30% of the capillary vessels in the central circle, as observed using fluorescein angiography
  2. Patients with a history of focal steroid treatment in the study eye within 4 months
  3. Patients with a history of anti-VEGF agent injection in the study eye within 3 months
  4. Patients with rubeosis iridis, vitreous hemorrhage or tractional retinal detachment in the study eye
  5. Patients with uncontrolled glaucoma in the study eye
  6. Patients with active inflammation or infection in the study eye (in or around the eye)
  7. Patients with disorders in the study eye that may confuse interpretation of the clinical trial results, cause severe visual loss, and require medical or surgical intervention during the study, based on the investigator's judgment (media opacity such as corneal opacity, cataract, and vitreous opacity, vitreous macular traction, uveitis, macular atrophy, macular degeneration, choroidal neovascularization, retinal vascular occlusion)
  8. Persons with a history of treatment with anti-VEGF drugs within the past 6 months, or if they anticipate future use (e.g.: sorafenib (Nexavar®), sunitinib (Sutent®), bevacizumab (Avastin®))
  9. Persons with confirmed allergy to fluorescein, indocyanine green or iodine
  10. Patients with a clinically significant disorder such as uncontrolled renal failure that would make it difficult for them to participate in this study, based on the investigator's judgment
  11. Pregnant or lactating woman
  12. Patient not using contraception or with a possibility of pregnancy during the clinical trial period
  13. Other persons deemed to be difficult to participate in this study, based on the investigator's judgment
  14. Persons participating in a study other than observational or non-interventional study

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 Assignment
  • Masking: Double

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.
Experimental: Selective Retina Therapy and ranibizumab combination therapy

Perform R:GEN laser (SRT) on the 6,000 microns diameter region including macular edema, while excluding the 500 microns diameter region from the fovea, with the appropriate treatment energy determined.

Ranibizumab (Lucentis®; Novartis AG, Basel, Switzerland) injection into the vitreous cavity at 3.5-4.0 mm posterior to the corneal limbus, towards the center of the eye, avoiding horizontal meridians. Then, 0.05 mL of the injection solution is slowly injected.

In study group and the control group, ranibizumab is administered 5 times in total from the baseline to month 4.
Combination product: R:GEN laser treatment (Selective Retina Therapy) and Lucentis (ranibizumab) combination therapy
Lucentis (ranibizumab) injection into the vitreous cavity after R:GEN laser treatment (Selective Retina Therapy)
Sham Comparator: Sham Selective Retina Therapy and ranibizumab monotherapy

For the participants assigned to the control group, sham procedures are performed in Sham Mode. All procedures except for the absence of laser light emission at the laser irradiation stage are the same with the study group.

Sham SRT is performed three times in total, one time for each visit for month 1, 3, and 5. At the time of month 1 and 3, Sham SRT should be performed before administration of ranibizumab.
Combination product: R:GEN laser treatment (Selective Retina Therapy) and Lucentis (ranibizumab) combination therapy
Lucentis (ranibizumab) injection into the vitreous cavity after R:GEN laser treatment (Selective Retina Therapy)

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
Best Corrected Visual Acuity (BCVA) change in the study group
Time Frame: 12 months
Compare BCVA change evaluated between the group where Ranibizumab was combined with R:GEN (Selective Retina Therapy) and the group where Ranibizumab monotherapy was applied
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity (BCVA) change in the study group
Time Frame: 12, 24 months
Compare BCVA change evaluated between the group where Ranibizumab was combined with R:GEN (Selective Retina Therapy) and the group where Ranibizumab monotherapy was applied
12, 24 months
Central Macular Thickness (CMT) change in the study group
Time Frame: 12, 24 months
Compare CMT change evaluated between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
12, 24 months
Maximum Macular Thickness (MMT) change in the study group
Time Frame: 12, 24 months
Compare MMT change evaluated between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
12, 24 months
Rate and number of Ranibizumab re-performance in the study group
Time Frame: 24 months
Compare the rate of participants who received Ranibizumab re-performance and the number of Ranibizumab re-performance between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
24 months
Adverse Event analysis
Time Frame: 24 months
Evaluate safety by comparing the rate of participants who experienced Adverse Event.
24 months

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.
LUTRONIC Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hakyung Kim, Professor, Hallym University Kangnam Sacred Heart Hospital

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 (Actual)

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.
January 8, 2018

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.
July 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

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).
November 27, 2018

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.
November 28, 2018

First Posted (Actual)

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.
November 30, 2018

Study Record Updates

Last Update Posted (Actual)

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.
November 30, 2018

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.
November 28, 2018

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.
November 1, 2018

More Information

Terms related to this study

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.
  • CSDME_P01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Drug Interventions

Conditions

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Dietary Supplements

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