The purpose of this study is to determine the effectiveness and safety of triamcinolone acetonide in patients with serous pigment detachment associated with age-related macular degeneration
The purpose of this study is to determine the effectiveness and safety of triamcinolone acetonide in patients with serous pigment epithelial detachment associated with age-related macular degeneration. This study is planned as a follow-up. Patients with with serous pigment epithelial detachment associated with age-related macular degeneration included in it will receive triamcinolone acetonide 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination.
Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination.
Ophthalmic examination
Odessa National Medical University
Odesa, Please Select, Ukraine
CPUkraine
Kyiv, Ukraine
Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, Ukraine
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine
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.
Time frame: Baseline-Month 12
Number of Flattened Pigment Epithelial Detachment
Number of flattened pigment epithelial detachment
Time frame: Baseline-Month 12
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence
A negative number indicates improvement (reduced thickness).
Time frame: Baseline-Month 12
Average Number of Injections
The number of injections administered
Time frame: Baseline-Month 12
Intraocular pressure
The difference between intraocular pressure at baseline and at Month 12
Time frame: Baseline-Month 12
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Ophthalmic examination
Ophthalmic examination
Ophthalmic examination
Ophthalmic examination
Ophthalmic examination
Ophthalmic examination