Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06115005
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Macular Holes	Biological: Plasma rich in growth factors ( PRGF )	Phase 2

Detailed Description

Challenging full thickness macular holes ( FTMH) include :

Recurrent FTMH Persistent (refractory) FTMH Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm. 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 Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Aug 1, 2024

Outcome Measures

Primary Outcome Measures

1. Number of participants that revealed closure of challenging macular holes [6 months]

   By clinical examination and OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University Hospital	Minya		Egypt

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arias JD, Hoyos AT, Alcantara B, Sanchez-Avila RM, Arango FJ, Galvis V. PLASMA RICH IN GROWTH FACTORS FOR PERSISTENT MACULAR HOLE: A PILOT STUDY. Retin Cases Brief Rep. 2022 Mar 1;16(2):155-160. doi: 10.1097/ICB.0000000000000957.
• Mahmoud TH, Thompson JT. The Treatment of Difficult Macular Holes. Ophthalmol Retina. 2021 Apr;5(4):315-316. doi: 10.1016/j.oret.2021.02.002. No abstract available.

• Responsible Party: Hossam Mohamed Moharram, Professor Doctor, Minia University
• ClinicalTrials.gov Identifier: NCT06115005
• Other Study ID Numbers: 360:2022
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Perforations; Mitogens

Study Results

No Results Posted as of Nov 2, 2023