Retinal Artery MacroaneurysmRAMNCT05716932
Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.
An observational study of Retinal Artery Macroaneurysm, run by Dar El Oyoun Hospital at 1 site in Egypt.
Trial summary
Treatment options for Retinal artery Macroaneurysm (RAM) include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Artery Macroaneurysm
- What is being tested?
- Dual focal laser and intravitreal Ranibizumab injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Dec 2022to 21 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrospective review of records of eyes with RAM; treated between February 2012 and November 2020; will be done, to collect and analyze the following data: Treatment details, features of RAM, associated retinal disease, best-corrected visual acuity (BCVA), central macular thickness (CMT), signs of RAM involution, and possible complications
Who may be able to join
- We will enroll cases of RAM that had been treated by Direct and perilesional focal laser, followed by a single intravitreal ranibizumab injection a few days later, and had been followed up for at least 6 months
Who cannot join
- • RAM treated by a single approach (laser or intravitreal injections),
- RAM treated by other anti-VEGF injections (not ranibizumab),
- RAM with a shorter than 6 months of follow-up after combined laser and ranibizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Focal Laser Photocoagulation Followed by a Single Intravitreal Ranibizumab Injection for Retinal Artery Macroaneurysm.
Treatment options for Retinal artery Macroaneurysm (RAM) include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]
However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]
.
Read the detailed description
Retinal arterial macroaneurysm (RAM) is an acquired localized arterial dilatation, which often occurs at second or third branches of the central retinal artery. Mostly, elderly hypertensive females above 60 years are affected. One in 4500 people over the age of 40 years is liable to develop a RAM. It may be associated with retinal vein occlusion. [1]
The natural history of a RAM can be divided into a growing phase, followed by gradual fibrosis and/ or thrombosis (closure), and then involution. A growing macroaneurysm may leak, resulting in intraretinal exudation and macular edema. It may rupture producing subretinal, intraretinal, preretinal, and / or vitreous hemorrhage. Approximately 8%-25% of RAMs undergo spontaneous involution without treatment. However, treatment is required for leaking macroaneurysms to prevent macular structural damage. [2,3]
Treatment options for RAM include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]
However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]
.
- Conditions
- Retinal Artery Macroaneurysm
- Being tested
- Dual focal laser and intravitreal Ranibizumab injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual focal laser and intravitreal Ranibizumab injectionProcedure or surgery
Also called DFL and IVR
Direct and perilesional focal laser followed by a single intravitreal 0.5 mg ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA, USA) injection
What is being measured
The primary outcome is the main question the study is designed to answer.
change in best corrected visual acuity (BCVA)
NCVA change between baseline and final follow up at 6 months
Measured: 6 months
Secondary outcomes (2)
change in central macular thickness (CMT)
between baseline and final follow up at 6 months
Measured: (Time frame: 6 months)
incidence of complications due to laser or intravitreal injection.
presence or absence of complications
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 posted8 Feb 2023
- Study start22 Dec 2022
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Artery MacroaneurysmStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar El Oyoun Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Wael Ahmed Ewais, Dar El Oyoun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716932
- Sponsor's protocol ID
- N-122-2022
- Acronym
- RAM
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Focal Laser Photocoagulation Followed by a Single Intravitreal Ranibizumab Injection for Retinal Artery Macroaneurysm.
- ClinicalTrials.gov ID
- NCT05716932
- Acronym / sponsor ID
- RAM / N-122-2022
- Conditions
- Retinal Artery Macroaneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dar El Oyoun HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 8 Feb 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.
Treatment options for Retinal artery Macroaneurysm (RAM) include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]
However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]
.
Detailed description
Retinal arterial macroaneurysm (RAM) is an acquired localized arterial dilatation, which often occurs at second or third branches of the central retinal artery. Mostly, elderly hypertensive females above 60 years are affected. One in 4500 people over the age of 40 years is liable to develop a RAM. It may be associated with retinal vein occlusion. [1]
The natural history of a RAM can be divided into a growing phase, followed by gradual fibrosis and/ or thrombosis (closure), and then involution. A growing macroaneurysm may leak, resulting in intraretinal exudation and macular edema. It may rupture producing subretinal, intraretinal, preretinal, and / or vitreous hemorrhage. Approximately 8%-25% of RAMs undergo spontaneous involution without treatment. However, treatment is required for leaking macroaneurysms to prevent macular structural damage. [2,3]
Treatment options for RAM include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]
However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]
.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective review of records of eyes with RAM; treated between February 2012 and November 2020; will be done, to collect and analyze the following data: Treatment details, features of RAM, associated retinal disease, best-corrected visual acuity (BCVA), central macular thickness (CMT), signs of RAM involution, and possible complications
Key inclusion criteria (1 listed)
- We will enroll cases of RAM that had been treated by Direct and perilesional focal laser, followed by a single intravitreal ranibizumab injection a few days later, and had been followed up for at least 6 months
Key exclusion criteria (3 listed)
- • RAM treated by a single approach (laser or intravitreal injections),
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 |
|---|---|---|
| Dual focal laser and intravitreal Ranibizumab injectionAlso: DFL and IVRDirect and perilesional focal laser followed by a single intravitreal 0.5 mg ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA, USA) injection | Procedure or surgery | – |
Primary outcome
change in best corrected visual acuity (BCVA)
Time frame: 6 months
NCVA change between baseline and final follow up at 6 months
2 secondary outcomes
change in central macular thickness (CMT)
Time frame: (Time frame: 6 months)
incidence of complications due to laser or intravitreal injection.
Time frame: 6 months
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 8 Feb 2023.
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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.
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?
An observational study of Retinal Artery Macroaneurysm, run by Dar El Oyoun Hospital 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 1 inclusion and 3 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 8 Feb 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.
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?
change in best corrected visual acuity (BCVA) (time frame: 6 months). 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 8 Feb 2023.