Non-Ischemic Central Retinal Vein Occlusion With Macular EdemaPhase 4NCT05282420
Ranibizumab Versus Aflibercept for CRVO in Young Patients.
A Phase 4 study testing intravitreal injection of Ranibizumab, intravitreal injection of Aflipercept and Ranibizumab in people with Non-Ischemic Central Retinal Vein Occlusion With Macular Edema, run by South Valley University at 1 site in Egypt.
Trial summary
this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
- What is being tested?
- intravitreal injection of Ranibizumab, intravitreal injection of Aflipercept and Ranibizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 31 May 2022
- Phase
- Phase 4
- 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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients younger than 50 years with macular edema due to non-ischemic CRVO
- Exclusion Criteria: Other conditions that might affect the macula as
- diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
- patients with ischemic type CRVO and patients who had recent intraocular surgery.
- patients who had previous intravitreal injections, ophthalmic laser surgeries.
- patients with dense cataracts whom fundus was difficult to scan.
- Patients who were lost to follow up visits were also excluded
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Ali Ahmed Amer
Qina, Qena Governorate, 83523
Ahmed A Ahmed Amer, MD, +201011827000, AhmedAli.ophth@gmail.com
About this study
Official title: Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.
this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old
Read the detailed description
This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.
Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\0.1ml. the second group will receive intravitreal injection of 2.0 mg\0.1 ml Aflibercept. All patients will be followed up for 12 months.
- Being tested
- intravitreal injection of Ranibizumab, intravitreal injection of Aflipercept, Ranibizumab, Aflibercept
- Keywords
- non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of RanibizumabProcedure or surgery
intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)
intravitreal injection of AfliperceptProcedure or surgery
intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)
RanibizumabDrug
Ranibizumab
AfliberceptDrug
Aflipercept
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab group | Active comparator | Ranibizumab injection monthly for 3 successive months Receives: Procedure: intravitreal injection of Ranibizumab; Drug: Ranibizumab |
| Aflibercept group | Active comparator | Aflibercept injection monthly for 3 successive months Receives: Procedure: intravitreal injection of Aflipercept; Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity BCVA
change BCVA after injection
Measured: at 12 months post-injection
Secondary outcomes (1)
reduction of macular edema
change in central subfield macular thickness CST on OCT
Measured: at 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Feb 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Ischemic Central Retinal Vein Occlusion With Macular EdemaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months. Patients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Ahmed Amer, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282420
- Sponsor's protocol ID
- SVU\MED\Oph026\4\21\12\284
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.
- ClinicalTrials.gov ID
- NCT05282420
- Acronym / sponsor ID
- SVU\MED\Oph026\4\21\12\284
- Keywords
- non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 16 Mar 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 will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old
Detailed description
This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.
Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\0.1ml. the second group will receive intravitreal injection of 2.0 mg\0.1 ml Aflibercept. All patients will be followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months. Patients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab group | Active comparator | Procedure: intravitreal injection of Ranibizumab, Drug: RanibizumabRanibizumab injection monthly for 3 successive months |
| Aflibercept group | Active comparator | Procedure: intravitreal injection of Aflipercept, Drug: AfliberceptAflibercept injection monthly for 3 successive months |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- patients younger than 50 years with macular edema due to non-ischemic CRVO
- Exclusion Criteria: Other conditions that might affect the macula as
- diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
- patients with ischemic type CRVO and patients who had recent intraocular surgery.
- patients who had previous intravitreal injections, ophthalmic laser surgeries.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| intravitreal injection of Ranibizumabintravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche) | Procedure or surgery | Ranibizumab group |
| intravitreal injection of Afliperceptintravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States) | Procedure or surgery | Aflibercept group |
| RanibizumabRanibizumab | Drug | Ranibizumab group |
| AfliberceptAflipercept | Drug | Aflibercept group |
Primary outcome
Best corrected visual acuity BCVA
Time frame: at 12 months post-injection
change BCVA after injection
1 secondary outcome
reduction of macular edema
Time frame: at 12 months post-injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Yes
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 4 study testing intravitreal injection of Ranibizumab, intravitreal injection of Aflipercept and Ranibizumab in people with Non-Ischemic Central Retinal Vein Occlusion With Macular Edema, run by South Valley 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 7 inclusion and 0 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 16 Mar 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity BCVA (time frame: at 12 months post-injection). 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 16 Mar 2022.