Clinical trial

Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

Name

360:2022

Description

Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Trial arms

Trial start

2022-06-01

Estimated PCD

2023-12-31

Trial end

2024-08-01

Status

Recruiting

Phase

Early phase I

Treatment

Plasma rich in growth factors ( PRGF )

Plasma rich in growth factors (PRGF) is characterized by a moderate concentration of platelets, in the absence of leukocytes. This absence of leukocytes is based on the fact that they synthesize matrix metalloproteinases, free radicals, and proinflammatory cytokines, which do not contribute and even impair the altered tissue regeneration

Size

Primary endpoint

Number of participants that revealed closure of challenging macular holes

6 months

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years 2. Challenging FTMH which include Recurrent macular holes Persistent(refractory) macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm Exclusion Criteria: * 1-Corneal opacities 2-Glaucomatous patients 3-Co-existing macular pathology ( e.g. diabetic retinopathy, vein occlusion and age related macular degeneration ) 4-History of PPV for any reason other than FTMH

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-11-02

1 organization

1 product

1 indication

Organization

Minia University

Product

Plasma rich in growth factors

Indication

Macular Hole