Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 3:39 PM
Study NCT ID:
NCT04332133
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2020-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Subthreshold Laser Versus Intravitreal Injection of Ranibizumab in Diabetic Macular Edema
Sponsor:
Minia University
Organization:
Study Overview
Official Title:
Anatomical and Functional Outcomes of Subthreshold Micropulse Laser Versus Intravitreal Ranibizumab Injection in Treatment of Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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 .
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 .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: