Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema

NCT04359771 | Completed Phase 4 Results FDA Device

• 1 other identifier: I-030416
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both economic and compliance problems to the patients.there is a growing evidence that recognises the effectiveness of the use of micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a subthreshold laser that is above the threshold of biochemical effect but below the threshold of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The current study was conducted in order to compare the efficacy of both MPL techniques in the treatment of center involving DME.

Conditions

Diabetic Retinopathy; Macula Edema

Keywords

micro-pulse laser; trans-foveal

Outcome Measures

Primary Outcomes (2)

• Change in Central Retinal Thickness (CRT)

  detecting changes in the thickness of the center of the macula

  baseline, at 1 month and 3 months after the intervention

• Change in the Best Corrected Visual Acuity (BCVA)

  detecting changes in the the best corrected visual acuity in logMAR. A LogMAR chart comprises rows of letters and is used by ophthalmologists, optometrists and vision scientists to estimate visual acuity. This chart was developed at the National Vision Research Institute of Australia in 1976, and is designed to enable a more accurate estimate of acuity than do other charts (e.g., the Snellen chart). For this reason, the LogMAR chart is recommended, particularly in a research setting. A Snellen score of 6/6 (20/20), indicating that an observer can resolve details as small as 1 minute of visual angle, corresponds to a LogMAR of 0 (since the base-10 logarithm of 1 is 0); a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small as 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is near-approximately 0.3), and so on.Therefore, a higher logMAR scores mean a worse outcome.

  baseline, at 1 month and 3 months after the intervention

Study Arms (2)

Yellow MPL

ACTIVE COMPARATOR

Device: Yellow micro-pulse laser

Diode MPL

ACTIVE COMPARATOR

Device: Diode micro-pulse laser

Interventions

Yellow micro-pulse laser DEVICE

applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea

Yellow MPL

Diode micro-pulse laser DEVICE

applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea

Diode MPL

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral diabetic macular edema
• center involving confirmed by Optical coherence tomogram (OCT)

You may not qualify if:

• any non-diabetic macular edema
• significant media opacities
• previous laser treatment, any intraocular surgery within the past 6 months
• previous intravitreal injections of any drug within the past 6 months

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

Location

Related Publications (2)

• Vujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.

  PMID: 25719988 BACKGROUND

• Scholz P, Altay L, Fauser S. A Review of Subthreshold Micropulse Laser for Treatment of Macular Disorders. Adv Ther. 2017 Jul;34(7):1528-1555. doi: 10.1007/s12325-017-0559-y. Epub 2017 May 24.

  PMID: 28540655 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Ahmed Abdelbaki
• Organization: faculty of medicine, Cairo University

a.abdelbaki@kasralainy.edu.eg

00201066642728

Study Officials

• Hany S Hamza, MD

  Cairo University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of ophthalmology

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: January 22, 2018
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: June 1, 2020
• Results First Posted: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Individual participant data (IPD) can be shared with researchers who are planning to conduct a similar study. Requests can be sent to the central contacts by email

Locations

EG (1)