ClinicalTrials.gg
RecruitingNCT06115005Updated Nov 2, 2023

Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors

A Phase 2 interventional study of Plasma rich in growth factors ( PRGF ) in Macular Holes, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Minia University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2022, registered Aug 2023).
  • Started Jun 2022; still recruiting 4 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Macular Holes

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03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years
  2. Challenging FTMH which include Recurrent macular holes Persistent() macular holes Macular holes in eyes with pathological myopia Large macular holes with an inner diameter of more than 650 µm

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Interventions

  • BiologicalPlasma 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

06

What researchers measure

Primary outcomes

  1. Number of participants that revealed closure of challenging macular holes

    By clinical examination and OCT

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 33814043 ↗
  • 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. PubMed 31895724 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2022 (actual). Primary completion is estimated for Dec 2023, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2023
First posted
Nov 2, 2023
StartActual
Jun 1, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
Aug 1, 2024
Last update
Nov 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06115005
Lead sponsor
Minia University
Responsible party
Hossam Mohamed Moharram (Professor Doctor, Minia University) — Principal investigator
First posted
Nov 2, 2023
Start date
Jun 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Nov 2, 2023

Study contacts

Zeyad A Askar, Assiss. lect
Contact
zeyadaskar@gmail.com
01060777052

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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