UveitisPhase 2IVASNCT02706704
Intravitreal Adalimumab Versus Subcutaneous Adalimumab in Non-infectious Uveitis
A Phase 2 study testing Adalimumab in people with Uveitis and Non-Infectious Uveitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Non-Infectious Uveitis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteLebanon
- Study dates
- Feb 2016to Jan 2022
- Phase
- Phase 2
- 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
Who may be able to join
- 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 corticosteroid 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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 corticosteroids 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 immunosuppressive 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
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.
- Conditions
- Uveitis, Non-Infectious Uveitis
- Being tested
- Adalimumab
- Keywords
- Intravitreal Adalimumab, Subcutaneous Adalimumab
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal | Active comparator | Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks. Receives: Drug: Adalimumab |
| Systemic | Active comparator | Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitreous Haze
Change in Vitreous Haze grade in each eye [National Eye Institute (NEI)/ Standardization of Uveitis Nomenclature (SUN) criteria]
Measured: 26 Weeks
Anterior Chamber Cells
Change in Anterior Chamber (AC) cell grade in each eye.
Measured: 26 Weeks
Secondary outcomes (4)
Visual Acuity
Change in ETDRS letters and logarithm of the minimum angle of resolution (log MAR) best-corrected visual acuity (BCVA) in each eye.
Measured: 26 Weeks
Macular Edema
Change in central retinal thickness on Optical Coherence Tomography (OCT).
Measured: 26 Weeks
Angiography Score
Change in fluorescein angiography score
Measured: 26 Weeks
Steroids Tapering
If the patient is initially on steroids (pre-enrolment); Success in tapering steroid dose as a response to the protocol.
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2022
- Study completionJan 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rola N Hamam, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706704
- Sponsor's protocol ID
- OPH.RH.07
- Acronym
- IVAS
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2016
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 25549063Santos 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 11586057Perez-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 15006008Rudwaleit 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 18662932Mansour 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 17322463Diaz-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 18476805Wu 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 21099452Androudi 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 20378179Manzano 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 21668348Tsilimbaris 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 19296122Jabs 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
- ClinicalTrials.gov ID
- NCT02706704
- Acronym / sponsor ID
- IVAS / OPH.RH.07
- Conditions
- Uveitis, Non-Infectious Uveitis
- Keywords
- Intravitreal Adalimumab, Subcutaneous Adalimumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 11 Mar 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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal | Active comparator | Drug: AdalimumabIntravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks. |
| Systemic | Active comparator | Drug: AdalimumabSubcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 corticosteroid equivalent):
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Adalimumab | Drug | Intravitreal, Systemic |
Primary outcome
Vitreous Haze
Time frame: 26 Weeks
Change in Vitreous Haze grade in each eye [National Eye Institute (NEI)/ Standardization of Uveitis Nomenclature (SUN) criteria]
Anterior Chamber Cells
Time frame: 26 Weeks
Change in Anterior Chamber (AC) cell grade in each eye.
4 secondary outcomes
Visual Acuity
Time frame: 26 Weeks
Macular Edema
Time frame: 26 Weeks
Angiography Score
Time frame: 26 Weeks
Steroids Tapering
Time frame: 26 Weeks
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 25549063Hamam 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.
- Background: PubMed 11586057Santos 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.
- Background: PubMed 15006008Perez-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.
- Background: PubMed 18662932Rudwaleit 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.
- Background: PubMed 17322463Mansour AM. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007 Mar;91(3):274-6. doi: 10.1136/bjo.2006.108050.
- Background: PubMed 18476805Diaz-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.
- Background: PubMed 21099452Wu 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.
- Background: PubMed 20378179Androudi 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.
- Background: PubMed 21668348Manzano 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.
- Background: PubMed 19296122Tsilimbaris 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.
- Background: PubMed 16196117Jabs 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.
- Individual participant dataSharing planned: No
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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.
Rola N Hamam, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab in people with Uveitis and Non-Infectious Uveitis, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 11 inclusion and 14 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: stopped early, as of the sponsor's last update on 2 Nov 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 Lebanon. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
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?
Vitreous Haze (time frame: 26 Weeks). The study lists 2 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 NCT02706704, which also lists 11 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 2 Nov 2026.