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

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
R:GEN laser treatment (Selective Retina Therapy) and Lucentis (ranibizumab) combination therapy
Sponsored by
LUTRONIC Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Kangnam Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Selective Retina Therapy and ranibizumab combination therapy

Sham Selective Retina Therapy and ranibizumab monotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity (BCVA) change in the study group
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

Secondary Outcome Measures

Best Corrected Visual Acuity (BCVA) change in the study group
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
Central Macular Thickness (CMT) change in the study group
Compare CMT change evaluated between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
Maximum Macular Thickness (MMT) change in the study group
Compare MMT change evaluated between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
Rate and number of Ranibizumab re-performance in the study group
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.
Adverse Event analysis
Evaluate safety by comparing the rate of participants who experienced Adverse Event.

Full Information

First Posted
November 27, 2018
Last Updated
November 28, 2018
Sponsor
LUTRONIC Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03759860
Brief Title
Laser (Selective Retina Therapy) and Drug Combined Intervention in Clinically Significant Diabetic Macular Edema
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LUTRONIC Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The participant must be masked from the information on the treatment group assignment. The BCVA and image (OCT, Color Fundus Photography (CFP), Fundus Autofluorescence (FAF), Fluorescence Angiography (FAG)) investigator of the institution must be blinded on the participants' treatment group assignment to eliminate bias in evaluation. Based on the images (OCT, CFP, FAF) and quantified measurement results (BCVA, OCT), the blinded principal investigator (independent evaluator) evaluates efficacy and adverse events and determines whether ranibizumab should be administered again. An investigator not blinded performs SRT and ranibizumab administration.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selective Retina Therapy and ranibizumab combination therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Selective Retina Therapy and ranibizumab monotherapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
R:GEN laser treatment (Selective Retina Therapy) and Lucentis (ranibizumab) combination therapy
Intervention Description
Lucentis (ranibizumab) injection into the vitreous cavity after R:GEN laser treatment (Selective Retina Therapy)
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA) change in the study group
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA) change in the study group
Description
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
Time Frame
12, 24 months
Title
Central Macular Thickness (CMT) change in the study group
Description
Compare CMT change evaluated between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
Time Frame
12, 24 months
Title
Maximum Macular Thickness (MMT) change in the study group
Description
Compare MMT change evaluated between the group where Ranibizumab was combined with R:GEN (SRT) and the group where Ranibizumab monotherapy was applied.
Time Frame
12, 24 months
Title
Rate and number of Ranibizumab re-performance in the study group
Description
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.
Time Frame
24 months
Title
Adverse Event analysis
Description
Evaluate safety by comparing the rate of participants who experienced Adverse Event.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults older than 19 years of age Patients with Type-I or Type-II diabetes 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. Central Macular Thickness (CMT) of study eye is more than 300㎛ on OCT Patients with BCVA of the study eye between 20/320 and 20/25. 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: 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 Patients with a history of focal steroid treatment in the study eye within 4 months Patients with a history of anti-VEGF agent injection in the study eye within 3 months Patients with rubeosis iridis, vitreous hemorrhage or tractional retinal detachment in the study eye Patients with uncontrolled glaucoma in the study eye Patients with active inflammation or infection in the study eye (in or around the eye) 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) 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®)) Persons with confirmed allergy to fluorescein, indocyanine green or iodine 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 Pregnant or lactating woman Patient not using contraception or with a possibility of pregnancy during the clinical trial period Other persons deemed to be difficult to participate in this study, based on the investigator's judgment Persons participating in a study other than observational or non-interventional study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakyung Kim, Professor
Organizational Affiliation
Hallym University Kangnam Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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