Presence of Retinal FluidNCT07074054
Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes
An observational study of Presence of Retinal Fluid and Changes in Macular Pigment Optical Density, run by Federico II University at 1 site in Italy.
Trial summary
Neovascular age-related macular degeneration (nAMD) is one of the main causes of irreversible vision loss in older people worldwide. the central role of vascular endothelial growth factor (VEFG) in the pathogenesis of nAMD has been extensively demonstrated. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Presence of Retinal Fluid, Changes in Macular Pigment Optical Density
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2024to 30 Mar 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients, over 50 years, diagnosed with naive nAMD, complicated by type 1 MNV, treated with aflibercept 8 mg
Who may be able to join
- age over 50 years; diagnosis of naïve nAMD due to the presence of active type 1 macular neovascularization (MNV)
Who cannot join
- previous ocular surgery, history of vitreoretinal and/or retinal vascular diseases, uveitis, myopia over 6 dioptres, significant corneal and/or lens opacity, glaucoma, ocular MNV related to other causes than nAMD, geographic atrophy, subretinal fibrosis, previous treatments for MNV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Anatomical and Functional Changes With Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: A Prospective Case Series
Neovascular age-related macular degeneration (nAMD) is one of the main causes of irreversible vision loss in older people worldwide.
the central role of vascular endothelial growth factor (VEFG) in the pathogenesis of nAMD has been extensively demonstrated. Since its introduction, intravitreal injection of targeted anti-VEGF antibodies has become the first-line treatment. Aflibercept 8 mg is a new formulation whose efficacy and safety as a new nAMD treatment has been demonstrated in the PULSAR study, emphasising its potential role in reducing the treatment burden in relation to the intended dosing intervals.
The aim of this study is to investigate early anatomical and functional changes in naïve nAMD patients treated with 8 mg aflibercept compared to patients treated with 2 mg aflibercept using OCT and MPOD, as potential parameters for functional outcome. To our knowledge, this is the first study to investigate these changes and the efficacy of aflibercept 8 mg as a potential fast-drying anti-VEGF treatment.
- Keywords
- nAMD, OCT, MPOD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with naive nAMD treated with aflibercept 8 mg | |
| Control group | Patients with naive nAMD treated with aflibercept 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPOD and OCT after aflibercept 8 mg loading phase
The parameters analyzed by OCT and MPOD 4 months after the treatment are: OCT and MPOD.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start15 Apr 2024
- Primary completion15 Apr 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Presence of Retinal FluidStudies of the same condition, open and under way.
- More trials run by Federico II 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074054
- Sponsor's protocol ID
- 05809857 Federico II
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rinaldi M, Cennamo G, Concilio M, Corvino G, Riccardo A, Nubi R, Costagliola C. Aflibercept 8 mg in Neovascular AMD-A Fast-Drying Anti-VEGF Drug: A Prospective Morpho-Functional Pilot Study. Ophthalmol Ther. 2026 Feb;15(2):677-687. doi: 10.1007/s40123-025-01296-8. Epub 2025 Dec 12.
PubMed 41388185
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anatomical and Functional Changes With Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT07074054
- Acronym / sponsor ID
- 05809857 Federico II
- Keywords
- nAMD, OCT, MPOD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 20 Jul 2025 (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.
Neovascular age-related macular degeneration (nAMD) is one of the main causes of irreversible vision loss in older people worldwide.
the central role of vascular endothelial growth factor (VEFG) in the pathogenesis of nAMD has been extensively demonstrated. Since its introduction, intravitreal injection of targeted anti-VEGF antibodies has become the first-line treatment. Aflibercept 8 mg is a new formulation whose efficacy and safety as a new nAMD treatment has been demonstrated in the PULSAR study, emphasising its potential role in reducing the treatment burden in relation to the intended dosing intervals.
The aim of this study is to investigate early anatomical and functional changes in naïve nAMD patients treated with 8 mg aflibercept compared to patients treated with 2 mg aflibercept using OCT and MPOD, as potential parameters for functional outcome. To our knowledge, this is the first study to investigate these changes and the efficacy of aflibercept 8 mg as a potential fast-drying anti-VEGF treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with naive nAMD treated with aflibercept 8 mg |
| Control group | – | –Patients with naive nAMD treated with aflibercept 2 mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients, over 50 years, diagnosed with naive nAMD, complicated by type 1 MNV, treated with aflibercept 8 mg
Key inclusion criteria (1 listed)
- age over 50 years; diagnosis of naïve nAMD due to the presence of active type 1 macular neovascularization (MNV)
Key exclusion criteria (1 listed)
- previous ocular surgery, history of vitreoretinal and/or retinal vascular diseases, uveitis, myopia over 6 dioptres, significant corneal and/or lens opacity, glaucoma, ocular MNV related to other causes than nAMD, geographic atrophy, subretinal fibrosis, previous treatments for MNV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MPOD and OCT after aflibercept 8 mg loading phase
Time frame: 7 months
The parameters analyzed by OCT and MPOD 4 months after the treatment are: OCT and MPOD.
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 20 Jul 2025.
- Derived from this study: PubMed 41388185Rinaldi M, Cennamo G, Concilio M, Corvino G, Riccardo A, Nubi R, Costagliola C. Aflibercept 8 mg in Neovascular AMD-A Fast-Drying Anti-VEGF Drug: A Prospective Morpho-Functional Pilot Study. Ophthalmol Ther. 2026 Feb;15(2):677-687. doi: 10.1007/s40123-025-01296-8. Epub 2025 Dec 12.
- Individual participant dataSharing planned: No
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 Presence of Retinal Fluid and Changes in Macular Pigment Optical Density, run by Federico II University at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 20 Jul 2025. 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 Italy. 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?
MPOD and OCT after aflibercept 8 mg loading phase (time frame: 7 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 NCT07074054, which also lists 1 linked publication.
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 20 Jul 2025.