Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT05464953

Collaborator

(none)

Enrollment

Location

Arms

27.3

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.

Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema of Left Eye	Drug: Triamcinolone Acetonide Drug: Formulated Triamcinolone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Alazher University Dean

Actual Study Start Date :

Jan 20, 2020

Actual Primary Completion Date :

Apr 20, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Formulated Posterior Sub Tenon Triamcinolone	Drug: Formulated Triamcinolone Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate
Active Comparator: Posterior Sub Tenon Triamcinolone alone	Drug: Triamcinolone Acetonide Triamcinolone Acetonide is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema
Active Comparator: suprachoroidal Triamcinolone	Drug: Triamcinolone Acetonide Triamcinolone Acetonide is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema

Arm

Intervention/Treatment

Active Comparator: Formulated Posterior Sub Tenon Triamcinolone

Drug: Formulated Triamcinolone

Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate

Active Comparator: Posterior Sub Tenon Triamcinolone alone

Drug: Triamcinolone Acetonide

Triamcinolone Acetonide is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema

Active Comparator: suprachoroidal Triamcinolone

Drug: Triamcinolone Acetonide

Outcome Measures

Primary Outcome Measures

BCVA [Base line]
Best-corrected visual acuity
BCVA [at 1st month]
Best-corrected visual acuity
BCVA [at 3rd month]
Best-corrected visual acuity
BCVA [at 6th month]
Best-corrected visual acuity
CMT [at baseline]
CENTRAL MACULAR THICKNESS
CMT [at 1st month]
CENTRAL MACULAR THICKNESS
CMT [at 3rd month]
CENTRAL MACULAR THICKNESS
CMT [at 6th month]
CENTRAL MACULAR THICKNESS

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diminution of vision due to diabetic macular edema.
CMT ≥ 250 µ.
Willing to participate in the study.

Exclusion Criteria:

Unwilling to participate in the study, 2)
Ischemic RVO,
previous laser treatment
Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion,
Cardiac co-morbidities result in significant hemodynamic changes, 7)Respiratory diseases need treatment with antibiotics,
Suffering from other chronic diseases as diabetes,
Patient with allergy from triamcinolone acetonide.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ehab tharwat	Damieta	New Damietta	Egypt	34517

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ehab tharwat, Dr, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05464953

Other Study ID Numbers:

PSTA and DME

First Posted:

Jul 19, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Edema

Edema

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Study Results

No Results Posted as of Jul 19, 2022