Amniotic Membrane Extract Eye DropsNCT06909149
Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers
A study testing Amniotic membrane extract eye drops and Specific treatment in people with Amniotic Membrane Extract Eye Drops and Resistant Corneal Ulcers, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to assess the efficacy of amniotic membrane extract eye drops (AMEED) as a supplementary treatment for refractory corneal ulcers. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Amniotic Membrane Extract Eye Drops, Resistant Corneal Ulcers
- What is being tested?
- Amniotic membrane extract eye drops and Specific treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 May 2022
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 20 to 80 years.
- Both sexes.
- Patients who were suffering from corneal ulcers that showed no signs of improvement after one week of medical intervention.
Who cannot join
- Severe corneal melting.
- Perforated corneal ulcer.
- Corneal ulcers with significant thinning with or without descemetocele.
- Patients who were unable to adhere to the treatment plan properly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers: A Randomized Clinical Trial Study
This study aimed to assess the efficacy of amniotic membrane extract eye drops (AMEED) as a supplementary treatment for refractory corneal ulcers.
Read the detailed description
Corneal ulceration is one of the leading causes of corneal blindness. Multiple causes of corneal ulceration vary in prevalence from country to country according to geographical and economic conditions.
Amniotic membrane (AM) contains pluripotent stem cells, highly organized collagen, immune-modulators, growth factors, anti-fibrotic and anti-inflammatory cytokines, A variety of matrix proteins, in addition to anti-microbial effect. Inspite of the amniotic membrane transplant is still a surgical procedure, it is not indicated in mild to moderate cases of resistant corneal ulceration and persistent epithelial defects and would alter visual function gravely.
Researchers found that amniotic membrane extract eye drops (AMEED) are superior to autologous blood serum in level and variety of growth factors, cytokines, and antimicrobial activity, along with higher success rates and faster healing results; they discarded the amniotic membrane conditioned medium as it failed to provide matching results.
- Being tested
- Amniotic membrane extract eye drops, Specific treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane extract eye dropsDrug
Patients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment.
Specific treatmentDrug
Patients received the specific treatment only.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane extract eye drops group | Experimental | Patients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment Receives: Drug: Amniotic membrane extract eye drops |
| Control group | Active comparator | Patients received the specific treatment only Receives: Drug: Specific treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of improvement of corneal ulcers
Time of improvement of corneal ulcers will be recorded.
Measured: 7 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 May 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Membrane Extract Eye DropsStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Sameh El-Shorbagy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909149
- Sponsor's protocol ID
- 33028/03/19
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers: A Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06909149
- Acronym / sponsor ID
- 33028/03/19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Apr 2025 (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.
This study aimed to assess the efficacy of amniotic membrane extract eye drops (AMEED) as a supplementary treatment for refractory corneal ulcers.
Detailed description
Corneal ulceration is one of the leading causes of corneal blindness. Multiple causes of corneal ulceration vary in prevalence from country to country according to geographical and economic conditions.
Amniotic membrane (AM) contains pluripotent stem cells, highly organized collagen, immune-modulators, growth factors, anti-fibrotic and anti-inflammatory cytokines, A variety of matrix proteins, in addition to anti-microbial effect. Inspite of the amniotic membrane transplant is still a surgical procedure, it is not indicated in mild to moderate cases of resistant corneal ulceration and persistent epithelial defects and would alter visual function gravely.
Researchers found that amniotic membrane extract eye drops (AMEED) are superior to autologous blood serum in level and variety of growth factors, cytokines, and antimicrobial activity, along with higher success rates and faster healing results; they discarded the amniotic membrane conditioned medium as it failed to provide matching results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane extract eye drops group | Experimental | Drug: Amniotic membrane extract eye dropsPatients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment |
| Control group | Active comparator | Drug: Specific treatmentPatients received the specific treatment only |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 20 to 80 years.
- Both sexes.
- Patients who were suffering from corneal ulcers that showed no signs of improvement after one week of medical intervention.
Key exclusion criteria (4 listed)
- Severe corneal melting.
- Perforated corneal ulcer.
- Corneal ulcers with significant thinning with or without descemetocele.
- Patients who were unable to adhere to the treatment plan properly.
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 |
|---|---|---|
| Amniotic membrane extract eye dropsPatients received the amniotic membrane extract eye drops once every two hours during waking time as an adjunctive therapy to the specific treatment. | Drug | Amniotic membrane extract eye drops group |
| Specific treatmentPatients received the specific treatment only. | Drug | Control group |
Primary outcome
Time of improvement of corneal ulcers
Time frame: 7 weeks after the procedure
Time of improvement of corneal ulcers will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic membrane extract eye drops and Specific treatment in people with Amniotic Membrane Extract Eye Drops and Resistant Corneal Ulcers, run by Tanta 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Apr 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of improvement of corneal ulcers (time frame: 7 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.