ClinicalTrials.gg
TerminatedNCT02706704IVASUpdated Nov 2, 2026

Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis

A Phase 2 interventional study of Adalimumab in Uveitis and Non-Infectious Uveitis, sponsored by American University of Beirut Medical Center. Terminated at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by American University of Beirut Medical Center · Phase 2, Interventional, and Treatment

Why this study was terminated
The trial was terminated prematurely due to factors unrelated to safety or efficacy outcomes. A severe nationwide shortage of adalimumab compounded by a financial crisis prevented the study from reaching its planned enrollment of 32 patients.
Updated Nov 2, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.

Read the detailed description

Subject groups:

32 subjects will be enrolled in this study, 16 in each arm. They will be randomized to receive either 1.5 mg/ 0.03 mL of adalimumab by intravitreal injection or 40 mg of adalimumab subcutaneously at their first treatment visit and at the 2 weeks visit if eligible for a repeat injection. Follow up will be every 2 days the first week then one week later and after that every 4-week intervals for total of 26 weeks.

Intervention Details:

  • Systemic adalimumab: Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.
  • Local adalimumab: Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.

Pre-treatment work up

Patients will undergo a comprehensive eye exam:

  • Visual acuity, slit-lamp examination of the anterior segment, dilated fundus examination, electroretinography (ERG) and fluorescein angiography (FA).
  • Central macular thickness of all eyes will be measured with ocular coherence tomography before treatment.
  • Purified Protein Derivative (PPD), Complete blood count (CBC) and SGPT.

Post-injection follow-up

  • Patients will be followed up every 2 days during the first week then one week later and after that every 4-week intervals.
  • On follow up visits, if deterioration in vision of two or more ETDRS lines or worsening of ocular inflammation by more than 1+ cells/haze is detected at any visit, patients will be removed from the study and receive appropriate treatment. Otherwise, if vision was stable or improved and/or inflammation is same or better, patients will be re-injected.
  • Follow up is for 26 weeks.
  • OCT and fluorescein angiography each visit.
  • ERG will be performed at baseline and 26 weeks.
  • Blood studies (CBC and SGPT) will be performed at baseline, 14 weeks and at 26 weeks.
  • Injections would be delayed if a patient has an acute infection and would be given when it subsides.
02

Conditions studied

  • Uveitis
  • Non-Infectious Uveitis

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Keywords

  • Intravitreal Adalimumab
  • Subcutaneous Adalimumab
03

In context

Uveitis

299 studies on the registry are indexed under Uveitis; 32 are open to participants now.

This study's enrollment of 23 is below the median of 30 across 175 interventional studies indexed under Uveitis.

Browse Uveitis studies →

Lead sponsor

American University of Beirut Medical Center is the lead sponsor of 158 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is ≥ 18 years of age.
  • Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
  • Subject must have active disease at baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of prednisone ≥ 10 mg/day (or oral equivalent):

    • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
    • ≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
    • ≥ 1+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
  • Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
  • If subject is on prednisone >=10 mg (or corticosteroid equivalent) at baseline, the dose has not been increased or decreased in the past 14 days.
  • No increase in the immune modulatory therapy in the past three months
  • Negative PPD test.
  • Positive PPD test on anti Tb medications.

Exclusion criteria

Exclusion Criteria:

  • Subject with isolated anterior uveitis.
  • Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus, lyme disease, toxoplasmosis and herpes simplex virus (HSV).
  • Subject with serpiginous choroidopathy.
  • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
  • Subject with corneal or lens opacities that preclude the evaluation of the vitreous haze.
  • Subject with uncontrolled high intraocular pressure of ≥ 25 mmHg on maximal therapy.
  • Subject with intermediate uveitis and symptoms and/or MRI findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis must have had a prior brain MRI at time of or after diagnosis of intermediate uveitis.
  • Subject has received glucocorticosteroids implant (Retisert®), or Ozurdex within 6 months prior to baseline visit.
  • Subject has received intraocular or periocular or intravitreal methotrexate within 90 days prior to Baseline visit.
  • Subject with proliferative or severe non-proliferative diabetic retinopathy.
  • Subject with neovascular/wet age-related macular degeneration
  • Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process.
  • Subject with a systemic inflammatory disease and requires additional therapy with a systemic agent at the time of study entry.
  • Subjects with history of active or latent Mycobacterium tuberculosis documented by Purified Protein Derivative (PPD) and chest X-ray and not anti tuberculosis (TB) treatment.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    Intravitreal

    Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.

    Drug: Adalimumab

  • Active comparator
    Systemic

    Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.

    Drug: Adalimumab

Interventions

06

What researchers measure

Primary outcomes

  1. Vitreous Haze

    Change in Vitreous Haze grade in each eye \[National Eye Institute (NEI)/ Standardization of Uveitis Nomenclature (SUN) criteria\]

    Time frame: 26 Weeks

  2. Anterior Chamber Cells

    Change in Anterior Chamber (AC) cell grade in each eye.

    Time frame: 26 Weeks

Secondary outcomes

  1. Visual Acuity

    Change in ETDRS letters and logarithm of the minimum angle of resolution (log MAR) best-corrected visual acuity (BCVA) in each eye.

    Time frame: 26 Weeks

  2. Macular Edema

    Change in central retinal thickness on Optical Coherence Tomography (OCT).

    Time frame: 26 Weeks

  3. Angiography Score

    Change in fluorescein angiography score

    Time frame: 26 Weeks

  4. Steroids Tapering

    If the patient is initially on steroids (pre-enrolment); Success in tapering steroid dose as a response to the protocol.

    Time frame: 26 Weeks

07

Study locations

1 site
  • American University of Beirut Medical Center
    Beirut, Lebanon
08

References and documents

Publications

  • Hamam RN, Barikian AW, Antonios RS, Abdulaal MR, Alameddine RM, El Mollayess G, Mansour AM. Intravitreal Adalimumab in Active Noninfectious Uveitis: A Pilot Study. Ocul Immunol Inflamm. 2016 Jun;24(3):319-26. doi: 10.3109/09273948.2014.990041. Epub 2014 Dec 30. PubMed 25549063 ↗
  • Santos Lacomba M, Marcos Martin C, Gallardo Galera JM, Gomez Vidal MA, Collantes Estevez E, Ramirez Chamond R, Omar M. Aqueous humor and serum tumor necrosis factor-alpha in clinical uveitis. Ophthalmic Res. 2001 Sep-Oct;33(5):251-5. doi: 10.1159/000055677. PubMed 11586057 ↗
  • Perez-Guijo V, Santos-Lacomba M, Sanchez-Hernandez M, Castro-Villegas Mdel C, Gallardo-Galera JM, Collantes-Estevez E. Tumour necrosis factor-alpha levels in aqueous humour and serum from patients with uveitis: the involvement of HLA-B27. Curr Med Res Opin. 2004;20(2):155-7. doi: 10.1185/030079903125002847. PubMed 15006008 ↗
  • Rudwaleit M, Rodevand E, Holck P, Vanhoof J, Kron M, Kary S, Kupper H. Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study. Ann Rheum Dis. 2009 May;68(5):696-701. doi: 10.1136/ard.2008.092585. Epub 2008 Jul 28. PubMed 18662932 ↗
  • Mansour AM. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007 Mar;91(3):274-6. doi: 10.1136/bjo.2006.108050. PubMed 17322463 ↗
  • Diaz-Llopis M, Garcia-Delpech S, Salom D, Udaondo P, Hernandez-Garfella M, Bosch-Morell F, Quijada A, Romero FJ. Adalimumab therapy for refractory uveitis: a pilot study. J Ocul Pharmacol Ther. 2008 Jun;24(3):351-61. doi: 10.1089/jop.2007.0104. PubMed 18476805 ↗
  • Wu L, Hernandez-Bogantes E, Roca JA, Arevalo JF, Barraza K, Lasave AF. intravitreal tumor necrosis factor inhibitors in the treatment of refractory diabetic macular edema: a pilot study from the Pan-American Collaborative Retina Study Group. Retina. 2011 Feb;31(2):298-303. doi: 10.1097/IAE.0b013e3181eac7a6. PubMed 21099452 ↗
  • Androudi S, Tsironi E, Kalogeropoulos C, Theodoridou A, Brazitikos P. Intravitreal adalimumab for refractory uveitis-related macular edema. Ophthalmology. 2010 Aug;117(8):1612-6. doi: 10.1016/j.ophtha.2009.12.011. Epub 2010 Apr 8. PubMed 20378179 ↗
  • Manzano RP, Peyman GA, Carvounis PE, Damico FM, Aguiar RG, Ioshimoto GL, Ventura DF, Cursino ST, Takahashi W. Toxicity of high-dose intravitreal adalimumab (Humira) in the rabbit. J Ocul Pharmacol Ther. 2011 Aug;27(4):327-31. doi: 10.1089/jop.2010.0174. Epub 2011 Jun 13. PubMed 21668348 ↗
  • Tsilimbaris M, Diakonis VF, Naoumidi I, Charisis S, Kritikos I, Chatzithanasis G, Papadaki T, Plainis S. Evaluation of potential retinal toxicity of adalimumab (Humira). Graefes Arch Clin Exp Ophthalmol. 2009 Aug;247(8):1119-25. doi: 10.1007/s00417-009-1065-y. Epub 2009 Mar 19. PubMed 19296122 ↗
  • Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. PubMed 16196117 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Feb 2016 to primary completion in Jan 2022, 71 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Dec 2025 → Jan 2022 and completion Feb 2026 → Jan 2022.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2016
First posted
Mar 11, 2016
StartActual
Feb 2016
Primary completionActual
Jan 2022was Dec 2025
CompletionActual
Jan 2022was Feb 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Terminated The trial was terminated prematurely due to factors unrelated to safety or efficacy outcomes. A severe nationwide shortage of adalimumab compounded by a financial crisis prevented the study from reaching its planned enrollment of 32 patients.
changed Nov 2, 2026
Primary completion
Dec 2025→Jan 2022 (actual)
Nov 2, 2026
Study completion
Feb 2026→Jan 2022 (actual)
Nov 2, 2026
Enrollment
32 (estimated)→23 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Terminated
    Why stopped The trial was terminated prematurely due to factors unrelated to safety or efficacy outcomes. A severe nationwide shortage of adalimumab compounded by a financial crisis prevented the study from reaching its planned enrollment of 32 patients.
    Primary completion Dec 2025→Jan 2022 (now actual)
    Study completion Feb 2026→Jan 2022 (now actual)
    Enrollment 32 (estimated)→23 (actual)
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02706704
Responsible party
Sponsor
First posted
Mar 11, 2016
Start date
Feb 2016
Primary completion
Jan 2022
Completion
Jan 2022
Last update
Nov 2, 2026

Study contacts

Rola N Hamam, MD
principal investigator · American University of Beirut Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Adalimumab

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