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Birdshot ChorioretinopathyCO-BIRDNCT05153057

Birdshot Chorioretinopathy : Prospective Follow-up and Immunogenetic Studies(CO-BIRD)

An observational study of Birdshot Chorioretinopathy and Posterior Uveitis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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

The purpose of this study is twofold: 1. To analyze the clinical features of a cohort of patients with birdshot chorioretinopathy (BCR), an inflammatory bilateral ocular disease, affecting the choroid and the retina. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Birdshot Chorioretinopathy, Posterior Uveitis
What is being tested?
Observational study
How many people
600 participants
Where
1 siteFrance
Study dates
2 Nov 2004to 31 Dec 2030
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients followed in the Department of Ophthalmology in a Paris University Hospital. Tertiary center for rare inflammatory ocular disorders.

Who may be able to join

  • Bilateral disease
  • Presence of at least three peripapillary "birdshot lesions" inferior or nasal to the optic disk in one eye
  • Low-grade anterior segment intraocular inflammation (defined as ≤ 1+cells in the anterior chamber)
  • Low grade vitreous inflammatory reaction (defined as ≤ 2+ vitreous haze‡) Supportive findings
  • 1. HLA-A29 positivity 2. Retinal vasculitis 3. Cystoid macular edema

Who cannot join

  • Keratic precipitates
  • Posterior synechiae
  • Presence of infectious, neoplastic, or other inflammatory diseases that can cause multifocal choroidal lesions

Trial locations and contacts

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

Souhila KECILI, MSc contact

+33 1 58412898

souhila.kecili@aphp.fr

France1 site, 1 recruiting
  • Ophtalmopôle, Hôpital Cochin

    Paris, Île-de-France Region, 75014

    Souhila KECILI, MSc, +33 1 58412898, souhila.kecili@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Longitudinal Cohort Study of Patients With Birdshot Chorioretinopathy.

The purpose of this study is twofold:

  1. To analyze the clinical features of a cohort of patients with birdshot chorioretinopathy (BCR), an inflammatory bilateral ocular disease, affecting the choroid and the retina. Various imaging techniques will be used to assess the effect of the disease on the retina and the choroid. A standardized assessment of the visual function will be performed with visual acuity, visual field and color vision testing. The quality of life of the patients will be evaluated with the VFQ-25 questionnaire. These analyses will help delineating different forms of the disease among its heterogeneous presentations.
  2. To identify predisposing factors for the disease. The condition is unique from the immunogenetic standpoint by its association with the HLA-A29 allele, which is the strongest link between an HLA class I antigen and a disease. To date, however, the mechanisms leading to birdshot chorioretinopathy remain unknown. GWAS (Genome Wide association Study) based on DNA of the cohort patients will be performed with the aim to identify other susceptibility genes associated with BCR.
Read the detailed description

Birdshot chorioretinopathy is a bilateral chronic posterior uveitis that has been named in 1980. The "birdshot lesions" are the hallmark of the disease. In their most typical aspect these lesions are ovoid shaped hypopigmented spots at the level of the choroid.

One of the main difficulties of the diagnosis lies in the spectrum of presentations of the disease. The typical birdshot lesions are ovoid with their main axis oriented toward the optic disc. However, some are round and the can be clearly seen on fundus examination while others can be limited to subtle depigmentations. Typical lesions are one-quarter to one-half disc diameters, but confluent lesions may yield larger areas of depigmentation that are difficult to recognize. Although the typical lesions are depigmented, their presentation may change over time and pigment or atrophy may replace the initial cream-colored spots. The typical location, or the most easily seen location of the spots, is nasal to the optic disc. However, involvement of the posterior pole inside the temporal arcade is also possible. The spots usually predominate in the mid-periphery, but may also extend to the equator. A standardized classification of the birdshot lesions according to their size, their number, their pigmentation and their localization has been suggested to help in the categorization of the various disease presentations and for the longitudinal follow-up of affected patients. Spots clearly visible at the time of the diagnosis may disappear later. Hence, if the diagnosis of the birdshot chorioretinopathy is not made when spots are clearly visible, later presentations may not meet the definition commonly used for the disease. The disappearance of birdshot spots after treatment has been documented, but the effect of treatment on spots has not yet been assessed in large cohorts of patients. Indocyanine green angiography has been suggested as a reliable method to detect spots. However, it remains to be validated by a randomized assessment comparing indocyanine green angiography to color photographs for the detection of birdshot lesions.

Fluorescein angiography is useful in patients with birdshot chorioretinopathy to assess disease activity. In active disease, angiographic findings include leakage of the retinal veins, macular edema and optic disk hyperfluorescence. These findings are not disease specific, but they require a careful examination of the fundus seeking subtle spots when birdshot lesions are not obvious.

Given the above, the first goal of our prospective cohort study is to assess the heterogeneity of the disease, its spectrum of presentation and its evolution over time.

One of the characteristics of birdshot chorioretinopathy is its association with the HLA-A29 allele, which constitutes the strongest link between a disease and class I HLA allele. The mechanism by which HLA-A29 confers a risk for birdshot chorioretinopathy is a key question that remains unanswered. As with other associations between HLA class I antigens and diseases (HLA-B27 with spondylarthropathies and HLA B51 with Behçet's disease), the physiopathogeny of these links have not been elucidated.

Other factors playing a role in the physiopathogeny of the disease and not linked to the major histocompatibility complex are researched. A few families of patients with birdshot chorioretinopathy have been reported, which could point to additional genetic factors for disease susceptibility but does not rule out an environmental effect.

Hence, the complex physiopathology of birdshot chorioretinopathy could involve the HLA-A29 allele, other unknown genetic factors, as well as environmental factors.

Given the above, we are planning a GWAS (Genome Wide association Study) based on DNA of the cohort patients, which will be performed with the aim to identify other susceptibility genes associated with BCR.

Being tested
Observational study
Keywords
Prospective follow-up, birdshot chorioretinopathy.
Medical subject headings
Birdshot Chorioretinopathy, Uveitis, Posterior

What participants receive

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

  • Observational studyOther

    The goal of the study is purely observational. Treatment decisions will be made by physicians according to the grading of the intraocular inflammation related to birdshot chorioretinopathy and to their consequences on visual function. These treatment decisions will be independent from the observational study.

Study groups in NCT05153057
Study groupRoleWhat they receive
Birdshot chorioretinopathyPatients with a diagnosis of birdshot chorioretinopathy, with confirmed HLA-A29 positivity.
Receives: Other: Observational study

What is being measured

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

  1. Best Corrected Visual Acuity (BCVA)

    Standard decimal clarity for distance visual acuity. It is expressed from 0 which is minimum \& worse value, corresponding to no light perception; to 1.0 (20/20) which is maximum \& best value

    Measured: Through study completion, an average of 1 year

  2. Visual field testing

    Humphrey 30-2 automated threshold perimetry with foveal sensitivity. It is expressed in Mean Deviation from -25 decibels or unachievable which is minimum \& worse value, to 0 decibel, which is maximum \& best value.

    Measured: Through study completion, an average of 1 year

  3. Color vision

    Assessed with Desaturated Lanthony 15-Hue Test: an objective technic evaluating sensitivity to color \& colour vision deficiency. Test result is categorized as Abnormal for minimum \& worse evaluation; and Normal for maximum \& best evaluation.

    Measured: Through study completion, an average of 1 year

  4. National Eye Institute 25-Item Visual Function Questionnaire

    Using a scale from 0 for minimum \& worse, to 100 for maximum \& best result; this questionnaire measures influence of visual impairment on various dimensions of quality of life such as emotional well-being and social functioning

    Measured: Through study completion, an average of 1 year

Secondary outcomes (6)
  1. Assessment of birdshot spot size

    It describes appearance of the birdshot spots as small for minimum or large for maximum.

    Measured: Through study completion, an average of 1 year

  2. Assessment of birdshot spot number

    Spots are counted and categorized as <10 for minimum value \& >50 for maximum

    Measured: Through study completion, an average of 1 year

  3. Assessment of birdshot spot localization

    Spots are categorized as Juxtapapillary, Equator \& Diffuse.

    Measured: Through study completion, an average of 1 year

  4. Assessment of birdshot spot pigmentation

    Spot pigmentation is analysed and categorized as No pigmentation for minimum \& Sever for maximum.

    Measured: Through study completion, an average of 1 year

  5. Assessment of edema

    Papillary \& macular edema are analysed by Optical Coherence Tomography, using a scale from 0 to 4 respectively for minimum \& best, to maximum \& worse value.

    Measured: Through study completion, an average of 1 year

  6. Assessment of retinal vasculitis

    Arterial \& venous vasculitis are analysed by Fluorescein Angiography, using a scale from 0 to 4 respectively for minimum \& best, to maximum \& worse value.

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted10 Dec 2021
  2. Study start2 Nov 2004
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153057
Sponsor's protocol ID
NI16002
Acronym
CO-BIRD
Status last verified
Mar 2026
First submitted
12 Jan 2021
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sharing of anonymized clinical data with other investigators experienced in the care of patients with birdshot chorioretinopathy.

Publications

  • Levinson RD, Brezin A, Rothova A, Accorinti M, Holland GN. Research criteria for the diagnosis of birdshot chorioretinopathy: results of an international consensus conference. Am J Ophthalmol. 2006 Jan;141(1):185-7. doi: 10.1016/j.ajo.2005.08.025.

    PubMed 16386995
  • Monnet D, Brezin AP, Holland GN, Yu F, Mahr A, Gordon LK, Levinson RD. Longitudinal cohort study of patients with birdshot chorioretinopathy. I. Baseline clinical characteristics. Am J Ophthalmol. 2006 Jan;141(1):135-42. doi: 10.1016/j.ajo.2005.08.067.

    PubMed 16386987
  • Monnet D, Brezin AP. Birdshot chorioretinopathy. Curr Opin Ophthalmol. 2006 Dec;17(6):545-50. doi: 10.1097/ICU.0b013e3280109479.

    PubMed 17065923
  • Holland GN, Shah KH, Monnet D, Brezin AP, Yu F, Nusinowitz S, Levinson RD. Longitudinal cohort study of patients with birdshot chorioretinopathy II: color vision at baseline. Am J Ophthalmol. 2006 Dec;142(6):1013-8. doi: 10.1016/j.ajo.2006.06.065. Epub 2006 Aug 2.

    PubMed 17157585
  • Monnet D, Levinson RD, Holland GN, Haddad L, Yu F, Brezin AP. Longitudinal cohort study of patients with birdshot chorioretinopathy. III. Macular imaging at baseline. Am J Ophthalmol. 2007 Dec;144(6):818-828. doi: 10.1016/j.ajo.2007.08.011. Epub 2007 Oct 18.

    PubMed 17949671
  • Gordon LK, Monnet D, Holland GN, Brezin AP, Yu F, Levinson RD. Longitudinal cohort study of patients with birdshot chorioretinopathy. IV. Visual field results at baseline. Am J Ophthalmol. 2007 Dec;144(6):829-837. doi: 10.1016/j.ajo.2007.08.010. Epub 2007 Oct 15.

    PubMed 17937923
  • Levinson RD, Du Z, Luo L, Monnet D, Tabary T, Brezin AP, Zhao L, Gjertson DW, Holland GN, Reed EF, Cohen JH, Rajalingam R. Combination of KIR and HLA gene variants augments the risk of developing birdshot chorioretinopathy in HLA-A*29-positive individuals. Genes Immun. 2008 Apr;9(3):249-58. doi: 10.1038/gene.2008.13. Epub 2008 Mar 13.

    PubMed 18340360
  • Kappel PJ, Monnet D, Yu F, Brezin AP, Levinson RD, Holland GN. Contrast sensitivity among patients with birdshot chorioretinopathy. Am J Ophthalmol. 2009 Feb;147(2):351-356.e2. doi: 10.1016/j.ajo.2008.08.021. Epub 2008 Oct 29.

    PubMed 18973873
  • Levinson RD, Monnet D, Yu F, Holland GN, Gutierrez P, Brezin AP. Longitudinal cohort study of patients with birdshot chorioretinopathy. V. Quality of life at baseline. Am J Ophthalmol. 2009 Feb;147(2):346-350.e2. doi: 10.1016/j.ajo.2008.08.011. Epub 2008 Oct 9.

    PubMed 18848319
  • Pagnoux C, Mahr A, Aouba A, Berezne A, Monnet D, Cohen P, Levinson RD, Brezin AP, Guillevin L. Extraocular manifestations of birdshot chorioretinopathy in 118 French patients. Presse Med. 2010 May;39(5):e97-e102. doi: 10.1016/j.lpm.2009.12.005. Epub 2010 Mar 10.

    PubMed 20219319
  • Brezin AP, Monnet D, Cohen JH, Levinson RD. HLA-A29 and birdshot chorioretinopathy. Ocul Immunol Inflamm. 2011 Dec;19(6):397-400. doi: 10.3109/09273948.2011.619295.

    PubMed 22106906
  • Dastiridou AI, Bousquet E, Kuehlewein L, Tepelus T, Monnet D, Salah S, Brezin A, Sadda SR. Choroidal Imaging with Swept-Source Optical Coherence Tomography in Patients with Birdshot Chorioretinopathy: Choroidal Reflectivity and Thickness. Ophthalmology. 2017 Aug;124(8):1186-1195. doi: 10.1016/j.ophtha.2017.03.047. Epub 2017 Apr 26.

    PubMed 28456419
  • Cunningham ET, Levinson RD, Denniston AK, Brezin AP, Zierhut M. Birdshot Chorioretinopathy. Ocul Immunol Inflamm. 2017 Oct;25(5):589-593. doi: 10.1080/09273948.2017.1400800. No abstract available.

    PubMed 29144845
  • Bousquet E, Khandelwal N, Seminel M, Mehanna C, Salah S, Eymard P, Bodin Hassani S, Monnet D, Brezin A, Agrawal R. Choroidal Structural Changes in Patients with Birdshot Chorioretinopathy. Ocul Immunol Inflamm. 2021 Feb 17;29(2):346-351. doi: 10.1080/09273948.2019.1681472. Epub 2019 Nov 12.

    PubMed 31714872
  • Ferreira de Moura T, Enjalbert A, Monnet D, Kecili S, Imikerene L, Loeliger J, Thorne JE, Brezin AP. Peripapillary atrophy in patients with birdshot chorioretinitis. Br J Ophthalmol. 2025 Jul 22;109(8):882-887. doi: 10.1136/bjo-2024-326440.

    PubMed 40010761

Questions about this trial

What is this clinical trial studying?

An observational study of Birdshot Chorioretinopathy and Posterior Uveitis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 3 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 4 Mar 2026. 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 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 Souhila KECILI, MSc (+33 1 58412898, souhila.kecili@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Corrected Visual Acuity (BCVA) (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. 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 NCT05153057, which also lists 17 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 4 Mar 2026.

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