Trials / Completed
CompletedNCT04292756
Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment
Safety and Effectiveness of Triamcinolone Acetonide in Patients With Serous Pigment Detachment Associated With Age-Related Macular Degeneration
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- The Filatov Institute of Eye Diseases and Tissue Therapy · Academic / Other
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Subtenon injection of 40 mg triamcinolone acetonide | Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination. |
| PROCEDURE | Intravitreal injection of 4 mg triamcinolone acetonide | Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination. |
| DIAGNOSTIC_TEST | Visometry | Ophthalmic examination |
| DIAGNOSTIC_TEST | Fluorescent angiography | Ophthalmic examination |
| DIAGNOSTIC_TEST | Refractometry | Ophthalmic examination |
| DIAGNOSTIC_TEST | Slit lamp examination | Ophthalmic examination |
| DIAGNOSTIC_TEST | Ophthalmoscopy | Ophthalmic examination |
| DIAGNOSTIC_TEST | OKT | Ophthalmic examination |
| DIAGNOSTIC_TEST | IOP | Ophthalmic examination |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2020-07-01
- Completion
- 2020-12-31
- First posted
- 2020-03-03
- Last updated
- 2022-08-23
Locations
4 sites across 1 country: Ukraine
Source: ClinicalTrials.gov record NCT04292756. Inclusion in this directory is not an endorsement.