Retinal NeovascularizationIVT-RNFLNCT02876198
Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF
An observational study of Retinal Neovascularization, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
Trial summary
The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Neovascularization
- What is being tested?
- Gonioscopy
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jul 2016to 15 Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited during a consultation in ophtalmology after prescription of an anti-VEGF treatment. The study will not change the patient's usual care schedule. Only a different analysis of the images obtained by SD -OCT will be performed, and a gonioscopy will be carried out systematically the inclusion of patient and 12 months. The data for the study will be collected at the inclusion visit and at the final visit of the study at 12 months.
Who may be able to join
- Age ≥18 years old
- Patients treated with anti-VEGF according to the French summary of product characteristics (SPC)
- Patients who have been informed of the trial and who are not opposed to participate in the study
Who cannot join
- Patients presenting a retinal condition, including the optic nerve
- Patients treated with anti-VEGF in both eyes
- Pregnant women
- Lack of affiliation to social security or universal health coverage
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Pole Vision du val d'Ouest
Lyon
Fondation Ophtalmologique A. de Rotchschild
Paris, 75019
Centre médical et chirurgical de la rétine
Strasbourg
About this study
The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.
- Conditions
- Retinal Neovascularization
- Being tested
- Gonioscopy
- Keywords
- Retinal neovascularization, Anti-VEGF, Retinal Nerve Fiber Layer (RNFL)
- Medical subject headings
- Retinal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GonioscopyDevice
Study of the trabecular structure by gonioscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with anti-VEGF | Not described Receives: Device: Gonioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF
RNFL's thickness (in microns) measured with the Heildelberg glaucoma module of the spectral domain Optical Cohérence Tomographie (OCT Spectralis, Heidelberg engeening).
Measured: Change from baseline RNFL's thickness at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jan 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal NeovascularizationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876198
- Sponsor's protocol ID
- MMT_2015_41
- Acronym
- IVT-RNFL
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2016
- Last updated
- 3 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF
- ClinicalTrials.gov ID
- NCT02876198
- Acronym / sponsor ID
- IVT-RNFL / MMT_2015_41
- Conditions
- Retinal Neovascularization
- Keywords
- Retinal neovascularization, Anti-VEGF, Retinal Nerve Fiber Layer (RNFL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with anti-VEGF | – | Device: Gonioscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited during a consultation in ophtalmology after prescription of an anti-VEGF treatment. The study will not change the patient's usual care schedule. Only a different analysis of the images obtained by SD -OCT will be performed, and a gonioscopy will be carried out systematically the inclusion of patient and 12 months. The data for the study will be collected at the inclusion visit and at the final visit of the study at 12 months.
Key inclusion criteria (3 listed)
- Age ≥18 years old
- Patients treated with anti-VEGF according to the French summary of product characteristics (SPC)
- Patients who have been informed of the trial and who are not opposed to participate in the study
Key exclusion criteria (4 listed)
- Patients presenting a retinal condition, including the optic nerve
- Patients treated with anti-VEGF in both eyes
- Pregnant women
- Lack of affiliation to social security or universal health coverage
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 |
|---|---|---|
| GonioscopyStudy of the trabecular structure by gonioscopy | Device | Patients treated with anti-VEGF |
Primary outcome
change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF
Time frame: Change from baseline RNFL's thickness at Month 12
RNFL's thickness (in microns) measured with the Heildelberg glaucoma module of the spectral domain Optical Cohérence Tomographie (OCT Spectralis, Heidelberg engeening).
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 Aug 2021.
Related trials for Retinal Neovascularization
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
RecruitingPhase 3
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Neovascularization, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF (time frame: Change from baseline RNFL's thickness at Month 12). 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 Aug 2021.