Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema:

• Sponsor: Dar El Oyoun Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05847088
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 36.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Intravitreal Dexamethasone Implant for refractory Diabetic macular edema:

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Intravitreal Dexamethasone Implant for Refractory Diabetic Macular Edema: Anatomical and Functional Outcomes of Treatment and Retreatment
• Actual Study Start Date: Feb 15, 2023
• Actual Primary Completion Date: Mar 28, 2023
• Actual Study Completion Date: Apr 4, 2023

Outcome Measures

Primary Outcome Measures

1. Change in Central macular thickness (in microns) (CMT change ) [between baseline and 6 months]

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

2. Change in Best corrected visual acuity (BCVA change) ) [between baseline and 6 months]

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

Secondary Outcome Measures

1. Number of DEX injections [between baseline and 6 months]

   Number of DEX injections

2. Shift to anti-VEGF during follow-up [between baseline and 6 months]

   Shift to anti-VEGF during follow-up (Yes or No)

3. Duration of follow-up ( months) [between baseline and 6 months]

   Duration of follow-up ( months)

4. CMT change > 100 u [between baseline and 6 months]

   CMT change > 100 u (yes / No)

5. CMT change > 200 u [between baseline and 6 months]

   CMT change > 200 u (yes / No)

6. BCVA change >= 2 lines [between baseline and 6 months]

   BCVA change >= 2 lines (yes / No)

7. Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD [between baseline and 6 months]

   Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD (yes / No)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr alainy faculty of medicine	Cairo		Egypt	12311

Sponsors and Collaborators

• Dar El Oyoun Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wael Ahmed Ewais, Associate professor of Ophthalmology Cairo university, Dar El Oyoun Hospital
• ClinicalTrials.gov Identifier: NCT05847088
• Other Study ID Numbers: N-21-2023
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Edema; Dexamethasone

Study Results

No Results Posted as of May 6, 2023