Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

NCT05031143 | Completed Phase 2 DMC

• 1 other identifier: FDASU-RECD-1234441
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection

Conditions

Vogt Koyanagi Harada Disease

Keywords

Vogt-koyanagi Harada, Suprachoroidal injection

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity (LogMAR units)

  Changes in vision from baseline upto 6 months follow up

  6 months after injection

Secondary Outcomes (1)

• Central Foveal Thickness measured by Optical Coherence Tomography

  Upto 6 months after SCTA injection

Other Outcomes (1)

• Intraocular pressure measured by Goldmann applanation tonometry

  6 months after injection

Study Arms (2)

SCTA injection (n=6 eyes)

ACTIVE COMPARATOR

Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.

Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

Non-injected eyes (Standard Treatment) (n=6 eyes)

NO INTERVENTION

Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months

Interventions

Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease DRUG

Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease

Also known as: SCTA for Exudative RD in VKH disease

SCTA injection (n=6 eyes)

Eligibility Criteria

• Age: 47 Years - 52 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.

You may not qualify if:

• recent intraocular surgery.
• patients refuse to participate in the study.
• media opacity and other causes of serous retinal detachment than VKH.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT

Banhā, Qualiobeya, 13511, Egypt

Location

MeSH Terms

Conditions

Uveomeningoencephalitic Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Uveal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ahmed Abdelshafy, MD

  Benha University, faculty of medicine

  PRINCIPAL INVESTIGATOR

• Marwa Abdelshafy, MD

  Benha University, faculty of medicine

  STUDY DIRECTOR

• Mohamed Anany, MD

  Benha University, faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: April 1, 2020
• Primary Completion: February 20, 2021
• Study Completion: August 24, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)