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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04119219
Other study ID # 0118U001612/3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 27, 2018
Est. completion date January 31, 2022

Study information

Verified date February 2021
Source The Filatov Institute of Eye Diseases and Tissue Therapy
Contact Andrii MD Korol, PhD
Phone +380936327266
Email andrii.r.korol@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to angioid streaks.


Description:

The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to angioid streaks. This study is planned as a follow-up. Patients with angioid streaks included in it will receive antiangiogenic therapy in accordance with the approved indications for use indicated in the instructions for the use of drugs in Ukraine. The treatment proposed in this study is based on the world experience and scientific developments of the Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine ". Therefore, it is expected that the benefit / risk ratio in relation to the participation in this study should not be different from that described in the scientific literature and the benefits outweigh the risk. It is known that the absence of treatment in these diseases leads to an irreparable loss of central vision.


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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intravitreal injection
Intravitreal injection to the regimen pro re nata.

Locations

Country Name City State
Ukraine Mykolaiv Region Ophthalmogical Hospital Mykolaiv
Ukraine Odessa National Medical University Odessa
Ukraine The Filatov Institute of Eye Diseases and Tissue Therapy Odessa

Sponsors (4)

Lead Sponsor Collaborator
The Filatov Institute of Eye Diseases and Tissue Therapy Central Polyclinic of Internal Affairs of Ukraine, Mykolaiv Region Ophthalmogical Hospital, Odessa National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning. Baseline-Month 12
Secondary Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) A negative number indicates improvement (reduced thickness). Baseline-Month 12
Secondary Average Number of Intravitreal Injections The number of intravitreal injections administered Baseline-Month 12
Secondary Number of Endophthalmitis after Intravitreal Injections The number of endophthalmitis registered in patients after intravitreal injections Baseline-Month 12