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Completed

NCT Number: NCT04332133

Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema

The aim of this study is To compare the anatomical and functional results of intravitreal( IV) injection of ranibizumab with sub threshold micropulse laser ( SML) in treatment of Diabetic macular edema (DME) both anatomically by spectral domain optical coherence tomography (SD OCT) and functionally by best-corrected visual acuity (BCVA) and multifocal electroretinogram (mfERG).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Diabetic macular edema (DME) causes significant visual loss in diabetic patients. About 20% and 40% of patients with Type 1 and Type 2 diabetes mellitus (DM), respectively, develop DME. One-third of diabetic patients who have had DM for more than twenty years will develop DME . Early impairment in the function of the middle and inner layers of the retina has been reported in diabetic patients before appearance of vascular complications . A good independent guide of macular function in patients with DME is multifocal electroretinogram (mfERG) readings from the macular area, which strongly associate with morphologic alterations in the macula. Some investigators suggested that temporal characteristic (implicit time) of mfERG waves are more important than amplitudes for evaluation of retinal function in diabetic patients. They concluded that patients with DM show temporal changes indicating delayed neural transmission due to local impairment of blood glucose metabolism. In contrast, others emphasize the importance of both parameters (implicit time and amplitude) in identifying retinal affection in DM.

Intravitreal (IV) injections of anti-vascular endothelial growth factor (VEGF) agents provided good visual outcomes in treatment of DME. However, IV anti-VEGF injections are expensive, need to be repeated many times and have the potential risk of causing endophthalmitis . Subthreshold micropulse laser (SML) treatment of DME has the same effect as conventional laser treatment, nonetheless, there is less damage to adjacent tissues of the burn area in the retinal pigment epithelium (RPE). SML allows laser emission to be divided into bursts of short cyclic pulses that remain for microseconds permitting substantial cooling amid these short pulses .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DME with BCVA<0.5 decimal Snellen acuity.
  • Controlled blood glucose (HbA1c) <6.5%.

Exclusion criteria

  • History of previous intraocular surgery,
  • History of previous laser treatment,
  • History of previous IV injection,
  • Macular disease or ischemia,
  • Proliferative diabetic retinopathy,
  • Vitreoretinal traction,
  • Interruption of external limiting membrane (ELM) or ellipsoid zone (EZ).
  • Dense media opacity,
  • Optic disc pathology
  • History of strokes or ischaemic heart diseases.
  • patients with (CST) > 400 µm on OCT .

Treatment and study plan

laser interference,INTRAVITREAL INJECTION

Procedure

sub threshold micro pulse laser for DME for group 1 and intravitreal injection of Ranibizumab for group 2

Primary outcomes

  1. central subfield thickness in micrometer

    Time frame: 6 months

    OCT for the macular area with measuring CST in micron

  2. p1 amplitude of mfERG

    Time frame: 6mnths

    p1 amplitude of multifocal ERG measured in nv/deg2

  3. BCVA

    Time frame: 6 months

    BCVA is measured in decimal of Snellen visual acuity

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2020
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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