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

NCT03759860 | Unknown Phase 4

• 1 other identifier: CSDME_P01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (5)

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

  12, 24 months

• Central Macular Thickness (CMT) change in the study group

  12, 24 months

• Maximum Macular Thickness (MMT) change in the study group

  12, 24 months

• Rate and number of Ranibizumab re-performance in the study group

  24 months

• Adverse Event analysis

  24 months

Study Arms (2)

Selective Retina Therapy and ranibizumab combination therapy

EXPERIMENTAL

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

Sham Selective Retina Therapy and ranibizumab monotherapy

SHAM COMPARATOR

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

Interventions

R:GEN laser treatment (Selective Retina Therapy) and Lucentis (ranibizumab) combination therapy COMBINATION_PRODUCT

Lucentis (ranibizumab) injection into the vitreous cavity after R:GEN laser treatment (Selective Retina Therapy)

Selective Retina Therapy and ranibizumab combination therapy; Sham Selective Retina Therapy and ranibizumab monotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Ranibizumab; Combined Modality Therapy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Hakyung Kim, Professor

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 30, 2018
• Study Start: January 8, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2020
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

KR (1)