Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological MyopiaNCT05562336
Optical Coherence Tomography Angiography Criteria Of The Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia (Comparative Study).
An observational study of Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia, run by Sohag University.
Trial summary
This study aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia
- What is being tested?
- Optical coherence tomography angiography
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2023
- Phase
- Observational
- 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
Study population: Cnv in age related macular degeneration and in pathological myopia
Who may be able to join
- Patients with age related macular degeneration should be at least 50 years of age with CNV with no other causes.
- Patients with pathological myopia where axial length more than 26 mm or refractive power more than -6 diopter with CNV in OCT with clear media and OCT-angio can be used.
Who cannot join
- Exclude other pathological causes of CNV .
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia.
Read the detailed description
All patients will be examined by optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-angio) .
The size, the location, the criteria of the choriodal neovascular membrane will be examined and imaged.
Study include 50 cases of CNV in age related macular degeneration and 50 cases of CNV in pathological myopia.
- Conditions
- Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia
- Being tested
- Optical coherence tomography angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDevice
Optical coherence tomography (OCT) is a noninvasive imaging method that uses reflected light to create pictures of the back of your eye
| Study group | Role | What they receive |
|---|---|---|
| Patients with age related macular degeneration with CNV | Not described Receives: Device: Optical coherence tomography angiography | |
| Patients with pathological myopia with CNV | Not described Receives: Device: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia
choroidal neo-vascular membrane identified by Optical Coherence Tomography Angiography
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological MyopiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Mostafa Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562336
- Sponsor's protocol ID
- Soh-Med-22-09-03
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hee MR, Baumal CR, Puliafito CA, Duker JS, Reichel E, Wilkins JR, Coker JG, Schuman JS, Swanson EA, Fujimoto JG. Optical coherence tomography of age-related macular degeneration and choroidal neovascularization. Ophthalmology. 1996 Aug;103(8):1260-70. doi: 10.1016/s0161-6420(96)30512-5.
PubMed 8764797Secretan M, Kuhn D, Soubrane G, Coscas G. Long-term visual outcome of choroidal neovascularization in pathologic myopia: natural history and laser treatment. Eur J Ophthalmol. 1997 Oct-Dec;7(4):307-16. doi: 10.1177/112067219700700401.
PubMed 9457451Miller DG, Singerman LJ. Vision loss in younger patients: a review of choroidal neovascularization. Optom Vis Sci. 2006 May;83(5):316-25. doi: 10.1097/01.opx.0000216019.88256.eb.
PubMed 16699445Kovach JL, Schwartz SG, Flynn HW Jr, Scott IU. Anti-VEGF Treatment Strategies for Wet AMD. J Ophthalmol. 2012;2012:786870. doi: 10.1155/2012/786870. Epub 2012 Feb 28.
PubMed 22523653
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Criteria Of The Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia (Comparative Study).
- ClinicalTrials.gov ID
- NCT05562336
- Acronym / sponsor ID
- Soh-Med-22-09-03
- Conditions
- Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Sep 2022 (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 aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia.
Detailed description
All patients will be examined by optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-angio) .
The size, the location, the criteria of the choriodal neovascular membrane will be examined and imaged.
Study include 50 cases of CNV in age related macular degeneration and 50 cases of CNV in pathological myopia.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with age related macular degeneration with CNV | – | Device: Optical coherence tomography angiography |
| Patients with pathological myopia with CNV | – | Device: Optical coherence tomography angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cnv in age related macular degeneration and in pathological myopia
Key inclusion criteria (2 listed)
- Patients with age related macular degeneration should be at least 50 years of age with CNV with no other causes.
- Patients with pathological myopia where axial length more than 26 mm or refractive power more than -6 diopter with CNV in OCT with clear media and OCT-angio can be used.
Key exclusion criteria (1 listed)
- Exclude other pathological causes of CNV .
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 |
|---|---|---|
| Optical coherence tomography angiographyOptical coherence tomography (OCT) is a noninvasive imaging method that uses reflected light to create pictures of the back of your eye | Device | Patients with age related macular degeneration with CNV, Patients with pathological myopia with CNV |
Primary outcome
choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia
Time frame: through study completion, an average of 1 year
choroidal neo-vascular membrane identified by Optical Coherence Tomography Angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 8764797Hee MR, Baumal CR, Puliafito CA, Duker JS, Reichel E, Wilkins JR, Coker JG, Schuman JS, Swanson EA, Fujimoto JG. Optical coherence tomography of age-related macular degeneration and choroidal neovascularization. Ophthalmology. 1996 Aug;103(8):1260-70. doi: 10.1016/s0161-6420(96)30512-5.
- Background: PubMed 9457451Secretan M, Kuhn D, Soubrane G, Coscas G. Long-term visual outcome of choroidal neovascularization in pathologic myopia: natural history and laser treatment. Eur J Ophthalmol. 1997 Oct-Dec;7(4):307-16. doi: 10.1177/112067219700700401.
- Background: PubMed 16699445Miller DG, Singerman LJ. Vision loss in younger patients: a review of choroidal neovascularization. Optom Vis Sci. 2006 May;83(5):316-25. doi: 10.1097/01.opx.0000216019.88256.eb.
- Background: PubMed 22523653Kovach JL, Schwartz SG, Flynn HW Jr, Scott IU. Anti-VEGF Treatment Strategies for Wet AMD. J Ophthalmol. 2012;2012:786870. doi: 10.1155/2012/786870. Epub 2012 Feb 28.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia, run by Sohag University.
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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arwa El-shabrakhity (0111 462 4205, arwa_mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia (time frame: through study completion, an average of 1 year). 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 NCT05562336, which also lists 4 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 30 Sep 2022.