Central Retinal Vein Occlusion With Macular EdemaPhase 1/2NCT04290195
Use of Ziv Aflibercept in Different Retinal Diseases
A Phase 1/2 study testing Ziv-Aflibercept 25 MG/ML [Zaltrap] in people with Central Retinal Vein Occlusion With Macular Edema, run by Amin El Sayed Nawar at 1 site in Egypt.
Trial summary
A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of… Read more about this study
- Who is it for?
- Ages 31 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Retinal Vein Occlusion With Macular Edema
- What is being tested?
- Ziv-Aflibercept 25 MG/ML [Zaltrap]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Jan 2020
- Phase
- Phase 1/2
- 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 31 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal CNV less than 2 months documented by fundus fluorescein angiography (FFA)and optical coherence tomography (OCT ) , pathological myopia more than 6 D was included .
Who cannot join
- Previous intraocular surgery .
- Coincident retinal pathology as diabetic retinopathy, retinal vein occlusion .
- CNV due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis.
- Extrafoveal myopic CNV .
- Patients received other lines of treatment for CNV like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti VEGF(vascular endothelial growth factor) agents.
- Known glaucoma , clinical suspicion of glaucoma or IOP(intraocular pressure) more than 20 mmHg.
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- Prior ocular inflammation.
- The presence of retinal degeneration.
- Patients who didnot complete 6 months of follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema
A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.
Read the detailed description
Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and OCT(optical coherence tomography) were performed for all patients .Injection was repeated as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.
- Being tested
- Ziv-Aflibercept 25 MG/ML [Zaltrap]
- Keywords
- myopic choroidal neovascularisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziv-Aflibercept 25 MG/ML [Zaltrap]Drug
Also called zaltrap
Intravitreal injection of 1.25 mg of ziv aflibercept in patients
| Study group | Role | What they receive |
|---|---|---|
| ziv aflibercept patients | Experimental | 20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO Receives: Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection
To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept
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 posted28 Feb 2020
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amin El Sayed Nawar
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Amin El Sayed Nawar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290195
- Sponsor's protocol ID
- 2AA
- Status last verified
- Oct 2021
- First submitted
- 23 Feb 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan WM, Ohji M, Lai TY, Liu DT, Tano Y, Lam DS. Choroidal neovascularisation in pathological myopia: an update in management. Br J Ophthalmol. 2005 Nov;89(11):1522-8. doi: 10.1136/bjo.2005.074716.
PubMed 16234465Nawar AE, Wasfy T, Shafik HM. Switching to ziv-aflibercept in resistant diabetic macular edema non responsive to ranibizumab injection. BMC Ophthalmol. 2022 Jun 29;22(1):287. doi: 10.1186/s12886-022-02503-x.
PubMed 35768859Nawar AE, Shafik HM. Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients. BMC Ophthalmol. 2020 Oct 19;20(1):414. doi: 10.1186/s12886-020-01679-4.
PubMed 33076864
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04290195
- Acronym / sponsor ID
- 2AA
- Keywords
- myopic choroidal neovascularisation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Amin El Sayed NawarUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 28 Feb 2020 (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.
A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.
Detailed description
Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and OCT(optical coherence tomography) were performed for all patients .Injection was repeated as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
| Arm | Type | Receives |
|---|---|---|
| ziv aflibercept patients | Experimental | Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO |
Who may qualify
- Ages
- 31 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal CNV less than 2 months documented by fundus fluorescein angiography (FFA)and optical coherence tomography (OCT ) , pathological myopia more than 6 D was included .
Key exclusion criteria (9 listed)
- Previous intraocular surgery .
- Coincident retinal pathology as diabetic retinopathy, retinal vein occlusion .
- CNV due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis.
- Extrafoveal myopic CNV .
- Patients received other lines of treatment for CNV like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti VEGF(vascular endothelial growth factor) agents.
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 |
|---|---|---|
| Ziv-Aflibercept 25 MG/ML [Zaltrap]Also: zaltrapIntravitreal injection of 1.25 mg of ziv aflibercept in patients | Drug | ziv aflibercept patients |
Primary outcome
Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection
Time frame: 6 months
To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept
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 11 Oct 2021.
- Results publication: PubMed 16234465Chan WM, Ohji M, Lai TY, Liu DT, Tano Y, Lam DS. Choroidal neovascularisation in pathological myopia: an update in management. Br J Ophthalmol. 2005 Nov;89(11):1522-8. doi: 10.1136/bjo.2005.074716.
- Derived from this study: PubMed 35768859Nawar AE, Wasfy T, Shafik HM. Switching to ziv-aflibercept in resistant diabetic macular edema non responsive to ranibizumab injection. BMC Ophthalmol. 2022 Jun 29;22(1):287. doi: 10.1186/s12886-022-02503-x.
- Derived from this study: PubMed 33076864Nawar AE, Shafik HM. Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients. BMC Ophthalmol. 2020 Oct 19;20(1):414. doi: 10.1186/s12886-020-01679-4.
- medical journal that contains multiple papersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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?
A Phase 1/2 study testing Ziv-Aflibercept 25 MG/ML [Zaltrap] in people with Central Retinal Vein Occlusion With Macular Edema, run by Amin El Sayed Nawar 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 9 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 11 Oct 2021. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection (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 NCT04290195, which also lists 3 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 11 Oct 2021.