Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

Diabetic Macular Edema Clinical Trial

Official title:

Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema: Anatomical and Functional Outcomes of Treatment and Retreatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847088
• Other study ID #: N-21-2023
• Status: Completed
• Start date: February 15, 2023
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Dar El Oyoun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing our results , evaluating both anatomical and functional outcomes of DEX therapy for refractory DME.

Description:

Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases of refractory DME, with both a single injection, and /or with retreatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 4, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• • Age: 16 or older (Adults)
• Sex: both
• NTDME with CMT >300 u
• < 10% reduction in CMT (than previous treatment)
• < 50 u reduction in CMT (than previous treatment)
• Worsening of BCVA > 1 line on E chart.
• Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF
• Pseudophakic eyes
• NPDR , PRP-treated PDR

Exclusion Criteria:

• • Phakic eyes
• Uncontrolled Glaucoma (IOP > 24 mmHg, or cup disc ratio 0.8 or more)
• Herpetic viral infection.
• Untreated PDR

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:
Intravitreal Dexamethasone implants (DEX) (0.7 mg) (Ozurdex, Allergan, Inc, Irvine, CA, USA) had been used with greater efficacy and safety in DME.

Locations

Country	Name	City	State
Egypt	Kasr alainy faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dar El Oyoun Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Central macular thickness (in microns) (CMT change )	Change in Central macular thickness (in microns) (CMT change )	between baseline and 6 months
Primary	Change in Best corrected visual acuity (BCVA change) )	lines of Change in Best corrected visual acuity (BCVA change) )	between baseline and 6 months
Secondary	Number of DEX injections	Number of DEX injections	between baseline and 6 months
Secondary	Shift to anti-VEGF during follow-up	Shift to anti-VEGF during follow-up (Yes or No)	between baseline and 6 months
Secondary	Duration of follow-up ( months)	Duration of follow-up ( months)	between baseline and 6 months
Secondary	CMT change > 100 u	CMT change > 100 u (yes / No)	between baseline and 6 months
Secondary	CMT change > 200 u	CMT change > 200 u (yes / No)	between baseline and 6 months
Secondary	BCVA change >= 2 lines	BCVA change >= 2 lines (yes / No)	between baseline and 6 months
Secondary	Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD	Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD (yes / No)	between baseline and 6 months