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GlaucomaOGANCT06274593

Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma

An observational study of Glaucoma, run by Nantes University Hospital at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
What is being tested?
OCT
Type of treatment
Medical device
How many people
50 participants
Where
2 sitesFrance
Study dates
27 Apr 2024to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Adult, Older adult

Study population: Patients followed at Nantes University Hospital for advanced glaucoma (MD>10dB in visual field) who had peripapillary angiography OCT, OCTrnfl and visual field at their follow-up consultation.

Who may be able to join

  • Men and women aged 18 and over
  • Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital
  • mean visual field deficit (MD) >10dB

Who cannot join

  • Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...)
  • PPR (retinal PanPhotocoagulation), retinal cerclage
  • Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa)
  • AMD and other macular pathologies that can lead to central visual field deficits
  • Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract)
  • Loss of fixation point preventing visual field formation Pregnant or breast-feeding women
Show all 9Show fewer
  • Protected adults under guardianship or curatorship
  • with unreliable visual fields (false positives and false negatives > 33%)
  • with an uninterpretable OCTrnfl or OCTa (artifact, low quality score)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-Baptiste Ducloyer, M.D contact

02 40 08 34 01

jeanbatiste.ducloyer@chu-nantes.fr

France2 sites, 2 recruiting
  • CHU Nantes

    Nantes, Nantes, 44000

    Ducloyer, MD; PhD, alexandra.poinas@chu-nantes.fr

    Recruiting
  • Jean-Baptiste Ducloyer

    Nantes, Nantes, 44093

    Jean-Baptiste Ducloyer, MD, jeanbaptiste.ducloyer@chu-nantes.fr

    Not yet recruiting

Other trials in France

About this study

Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.

To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.

The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).

Read the detailed description

Glaucoma is a chronic disease of the optic nerve characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second-leading cause of blindness after cataracts and the leading cause of irreversible blindness.

The pathophysiology and loss of retinal ganglion cells are partly explained by 2 main theories:

  • biomechanical theory, which takes into account the forces and deformations of the optic nerve linked to IOP (intraocular pressure) and to the anatomy of the optic nerve head, particularly at the level of the cribriform plate (a zone of deformable weakness surrounded by a rigid scleral shell),
  • the vascular theory, explained by abnormalities in the vascularization of the optic nerve and retina.

Optical coherence tomography angiography (OCTa) is a relatively new imaging method that has been on the market for around ten years.

It is a non-invasive method that provides qualitative and quantitative information on retinal vascularization and the optic nerve head. The movement of red blood cells is used as a contrast medium to differentiate blood vessels from static tissue.

In glaucoma, changes in the peripapillary vascular plexus (around the optic nerve head) can be observed and are topographically correlated with visual field and peripapillary nerve fiber deficits.

One of the challenges in monitoring glaucoma patients lies in detecting the progression of the disease with the help of various complementary examinations, including the visual field, peripapillary nerve fiber OCT (RNFL), and more recently, OCTa.

The visual field is used to detect areas of vision deficit (peripheral or sometimes central), known as scotomas, and to monitor their evolution. RNFL OCT measures the thickness of the optic nerve (in micrometers) in its various quadrants. OCTa measures vascular density, also by quadrant, around the optic nerve head.

A deterioration in any of these parameters can help guide therapeutic management by modifying medical treatment or proposing surgery to lower intraocular pressure in the affected eye.

One of the difficulties in monitoring glaucoma patients lies in detecting optic nerve thinning in patients with advanced optic nerve damage. It is now well known that at an advanced stage of the disease, measurement of optic nerve thickness on RNFL OCT can reach a "floor" effect: residual non-neuronal tissue limits the usefulness of detecting changes in neuronal tissue, and disease progression can only be detected by visual field monitoring.

Vascular density measured on OCTa appears to reach a plateau effect in a delayed manner compared with measurements obtained on peripapillary OCT (RNFL) and could enable better monitoring of disease progression in patients with advanced glaucoma.

Indeed, a new objective follow-up criterion measured with OCTa in clinical practice for patients with uninterpretable OCTrnfl would be a valuable tool for assessing the rate of glaucoma progression in these patients and thus defining the rate of monitoring and the decision to intensify treatment in the event of progression. This is all the more important as the treatments available for glaucoma are sometimes invasive (drainage devices, surgery, etc.). Assessing the benefit-risk balance therefore requires objective data for these patients.

To date, to our knowledge, there are no studies analyzing the evolution of OCT angiography in glaucoma patients.

The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).

Conditions
Glaucoma
Being tested
OCT
Keywords
glaucoma, OCTa, OCTrnfl
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCTDevice

    Peripapillary angiography (OCT) at baseline and each year during 3 year

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the progression of vascular density (VD) in advanced glaucoma patients.

    Progression of peripapillary vascular density (VD) (in percent) per sector (8 sectors) with 3-year follow-up.

    Measured: 3 year

  2. Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients.

    Progression of peripapillary nerve fiber thickness (RNFL, in µm) per sector (8 sectors) with 3-year follow-up.

    Measured: 3 year

  3. Compare the progression of visual field in advanced glaucoma patients.

    Progression of visual field deficit (in dB) by sector (8 sectors) with 3-year follow-up

    Measured: 3 year

Secondary outcomes (1)
  1. CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up

    Study of the correlation between CV-OCTrnfl and correlation between CV-OCTa (mean in µm)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start27 Apr 2024
  3. Primary completion27 Apr 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06274593
Sponsor's protocol ID
AP_JBD_MJ_003
Acronym
OGA
Status last verified
Jun 2026
First submitted
14 Feb 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Nantes University Hospital at 2 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 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-Baptiste Ducloyer, M.D (02 40 08 34 01, jeanbatiste.ducloyer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the progression of vascular density (VD) in advanced glaucoma patients. (time frame: 3 year). The study lists 3 primary outcomes in all. 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 24 Jun 2026.

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