Macular HolesPhase 2NCT06115005
Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
A Phase 2 study testing Plasma rich in growth factors ( PRGF ) in people with Macular Holes, run by Minia University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Holes
- What is being tested?
- Plasma rich in growth factors ( PRGF )
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya
Zeyad Askar, 01060777052
About this study
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
- Conditions
- Macular Holes
- Being tested
- Plasma rich in growth factors ( PRGF )
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma rich in growth factors ( PRGF )Biological
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that revealed closure of challenging macular holes
By clinical examination and OCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mohamed Moharram, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115005
- Sponsor's protocol ID
- 360:2022
- Status last verified
- Oct 2023
- First submitted
- 26 Aug 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33814043Arias 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Challenging Macular Holes Using Plasma Rich in Growth Factors
- ClinicalTrials.gov ID
- NCT06115005
- Acronym / sponsor ID
- 360:2022
- Conditions
- Macular Holes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the Study:To report the structural and visual outcomes of plasma rich in growth factors in closure of challenging macular holes
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | – |
Primary outcome
Number of participants that revealed closure of challenging macular holes
Time frame: 6 months
By clinical examination and OCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 33814043Mahmoud 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.
- Background: PubMed 31895724Arias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plasma rich in growth factors ( PRGF ) in people with Macular Holes, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeyad A Askar, Assiss. lect (01060777052, zeyadaskar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that revealed closure of challenging macular holes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.