Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

NCT05847088 | Completed DMC

• 1 other identifier: N-21-2023
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Change in Central macular thickness (in microns) (CMT change )

  Change in Central macular thickness (in microns) (CMT change )

  between baseline and 6 months

• Change in Best corrected visual acuity (BCVA change) )

  lines of Change in Best corrected visual acuity (BCVA change) )

  between baseline and 6 months

Secondary Outcomes (7)

• Number of DEX injections

  between baseline and 6 months

• Shift to anti-VEGF during follow-up

  between baseline and 6 months

• Duration of follow-up ( months)

  between baseline and 6 months

• CMT change > 100 u

  between baseline and 6 months

• CMT change > 200 u

  between baseline and 6 months

Interventions

Intravitreal Dexamethasone Implant for refractory Diabetic macular edema: DRUG

Intravitreal Dexamethasone implants (DEX) (0.7 mg) (Ozurdex, Allergan, Inc, Irvine, CA, USA) had been used with greater efficacy and safety in DME.

Also known as: Ozurdex

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective Review of records of patients with Non-tractional diffuse diabetic macular edema (NTDME), for whom Ozurdex had been used , in the period between 2016 and 2022.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dar El Oyoun Hospital: lead

Study Sites (1)

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

Location

MeSH Terms

Interventions

Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Ophthalmology Cairo university

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: February 15, 2023
• Primary Completion: March 28, 2023
• Study Completion: April 4, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)