Proliferative Diabetic Retinopathy (PDR)Phase 2NCT02735369

A Study Assessing Efficacy and Safety of OC-10X in the Treatment of PDR

A Phase 2 study testing 2% OC-10X in people with Proliferative Diabetic Retinopathy (PDR), run by OcuCure Therapeutics, Inc. at 1 site in Bangladesh.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Proliferative Diabetic Retinopathy (PDR)
What is being tested?: 2% OC-10X
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteBangladesh
Study dates: Dec 2014to Oct 2016
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

Male or female patients diagnosed with Proliferative Diabetic Retinopathy will be eligible if the following inclusion criteria are met:
Ability to provide approved written informed consent and complies with study-related procedures/assessments for the full duration of the study, having age ≥18 years.
Type 1 or Type 2 Diabetes Mellitus.
Proliferative Diabetic Retinopathy (level 61, 65, 71, or 75) in one or both eyes without evidence of significant vitreous/pre retinal hemorrhage that would limit photographic documentation of area of neovascularization and without pre-retinal fibrosis. If both eyes meet eligibility requirements, the less affected eye will be selected to receive investigational drug or placebo. The second eye will be treated with the standard of care. (e.g. panretinal laser photocoagulation).
Best-Corrected Visual acuity of 20/200 or better in each eye.
If female and:

Show all 10Show fewer

Of childbearing potential, agrees to use an acceptable method of birth control as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), for the duration of the study and for at least 2 weeks following the final dose of study drug or abstinence; or
Is postmenopausal for at least 1 year; or
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Is not pregnant or breastfeeding.

Who cannot join

Male or female patients diagnosed with Proliferative Diabetic Retinopathy will not be eligible in the study if any of the exclusion criteria are met:
Clinically significant systemic diseases/conditions that, in the opinion of the Investigator, could negatively affect the safety of the patient during the study on a as determined on a case by case basis (e.g., unstable medical status including uncontrolled blood pressure, cardiovascular disease, uncontrolled liver disease, glycemic control or significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant, hepatic, pulmonary, gastrointestinal or neurological diseases, cancer or BMI).
Participation in any other clinical study/trial within the past 30 days prior to randomization.
Current treatment for active systemic infection.
Known allergy to any component of the formulation or to topical anesthetics (e.g., benzalkonium chloride, fluorescein, etc.).
History of any psychiatric illness, which may impair the ability to provide written informed consent.

Show all 28Show fewer

Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
Positive for urinary screen testing of drugs of abuse (opiates, cannabinoids, amphetamines, barbiturates, benzodiazepines, cocaine).
History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
Use of anti-mitotic or anti-metabolite therapy within 2 months of enrollment.
Planned use of any ocular or systemic medications that the Investigator determines unacceptable during the study (i.e. anti-vascular endothelial growth factor [VEGF] therapy), with the exception of oral contraceptives and short-term use of over-the-counter analgesics during the study.
Any other concurrent condition that, in the opinion of the Investigator, would prevent completion of the clinical trial, including inability to comply with the study requirements.
Presence of significant fibrosis or gliosis of the neovascularization of the disc or retina.
Presence of tractional retinal detachment.
History of panretinal laser photocoagulation (PRP) for Proliferative Diabetic Retinopathy.
Patients likely to require treatment for diabetic macular edema during the study.
Any intraocular surgery or trauma within 6 months before trial enrollment.
History of chronic ocular disease that, in the opinion of the Investigator, will affect neovascular progression.
Myocardial infarction, other cardiac events requiring hospitalization, stroke, transient ischemic attack, or treatment for congestive heart failure within 6 months prior to randomization that, in the in the opinion of the Investigator, could negatively affect the safety of the patient during the study.
Current use of contact lenses.
Concurrent or anticipated use of ocular agents during the study period that are considered by the Investigator to interfere with the study objectives.
History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis within 2 months; history of herpes simplex keratitis.
An ocular condition is present (other than diabetes) that, in the opinion of the Investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
Substantial cataract that,
In the opinion of the Investigator, is likely to be causing decreased visual acuity by 3 lines or more (e.g.., cataract reducing acuity to 20/40 or worse).
Would interfere with photography of the retina.
Aphakia, uncontrolled glaucoma (in Investigator's judgment).
Inability to tolerate eye drops in the eye or to have eye drops correctly administered.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Bangladesh Eye Hospital
Dhaka, 1205

Other trials in Bangladesh

About this study

Official title: A Phase II, Randomized, Placebo-Controlled, Study Assessing Efficacy and Safety of OC-10X Ophthalmic Suspension in the Treatment of Proliferative Diabetic Retinopathy

The present study is intended to evaluate the efficacy and safety of topical OC-10X Ophthalmic Suspension in patients diagnosed with proliferative diabetic retinopathy (level 61, 65, 71, or 75). OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of choroidal neovascularization (CNV). Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without the traditional toxicity and works downstream independently of growth factors. As demonstrated by OcuCure's preclinical data, tubulin inhibition, using OC-10X, may be a promising new approach to the treatment of PDR and AMD. Like AMD, PDR is a major cause of blindness in adults and is also caused by the growth of abnormal blood vessels. Importantly, the Phase I Study found that OC-10X can be safely applied topically in human eyes without adverse ocular or systemic effects.

Currently, there are few options for the treatment of PDR. Clinical options, such as laser photocoagulation or vitrectomy, require surgery and can permanently impair patients' vision. With few treatment options available, administration of OC-10X as a topical therapy, along with its novel mechanism, has the potential to provide benefits to patients with ocular diseases associated with angiogenesis.

Conditions: Proliferative Diabetic Retinopathy (PDR)
Being tested: 2% OC-10X, Placebo Comparator

What participants receive

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

2% OC-10XDrug
Also called 2-Biphenyl-4-yl-2,3-dihydro-(1H)-quinazolin-4-one
2% OC-10X
Placebo ComparatorDrug
Also called Placebo
Placebo

Study groups in NCT02735369
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Comparator Receives: Drug: Placebo Comparator
2% OC-10X	Experimental	2% OC-10X Receives: Drug: 2% OC-10X

What is being measured

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

The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of neovascularization elsewhere in the retina (NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of neovascularization elsewhere in the retina (NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of "Posterior NVE" from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area change of area of "Posterior NVE" from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks

Secondary outcomes (12)

Change from baseline of regression of intraretinal microvascular abnormalities (IRMA) in PDR patients as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of intraretinal microvascular abnormalities (IRMA) in PDR patients as compared to Visit 6 (Week 24)for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of regression of intraretinal hemorrhage as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of intraretinal hemorrhage as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of regression of venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of regression of area of capillary non-perfusion beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of area of capillary non-perfusion beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of regression of intraretinal exudation (lipid) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of intraretinal exudation (lipid) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of regression of macular edema (central subfield thickness) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of macular edema (central subfield thickness) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of regression of macular volume as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of macular volume as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of best-corrected ETDRS visual acuity as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of best-corrected ETDRS visual acuity as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Change from baseline of macular thickness as measured by Optical Coherence Tomography (OCT) compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of macular thickness as measured by Optical Coherence Tomography (OCT) compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Measured: Baseline - 24 weeks
Number of patients requiring rescue treatment at the end of the study.
Number of patients requiring rescue treatment at the end of the study.
Measured: Baseline - 24 weeks
Number of patients requiring pars plana vitrectomy surgery due to presence of vitreous hemorrhage at the end of the study.
Number of patients requiring pars plana vitrectomy surgery due to presence of vitreous hemorrhage at the end of the study.
Measured: Baseline - 24 weeks
Number of patients requiring pars plana vitrectomy surgery due to traction retinal detachment at the end of the study.
Number of patients requiring pars plana vitrectomy surgery due to traction retinal detachment at the end of the study.
Measured: Baseline - 24 weeks

Timeline

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

Dec 2014Oct 2016

First posted12 Apr 2016 (estimated)
Study startDec 2014
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Proliferative Diabetic Retinopathy (PDR)Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02735369
Sponsor's protocol ID: OC10X-CT-BD2 PDR
Status last verified: Apr 2017
First submitted: 19 Jan 2016
Last updated: 5 Apr 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
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All Proliferative Diabetic Retinopathy (PDR) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Placebo-Controlled, Study Assessing Efficacy and Safety of OC-10X Ophthalmic Suspension in the Treatment of Proliferative Diabetic Retinopathy
ClinicalTrials.gov ID: NCT02735369
Acronym / sponsor ID: OC10X-CT-BD2 PDR
Conditions: Proliferative Diabetic Retinopathy (PDR)
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 40 participants (estimated)
Lead sponsor: OcuCure Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: Semler Research Center Pvt. Ltd.
Study start: Dec 2014
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 12 Apr 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo ComparatorPlacebo Comparator
2% OC-10X	Experimental	Drug: 2% OC-10X2% OC-10X

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female patients diagnosed with Proliferative Diabetic Retinopathy will be eligible if the following inclusion criteria are met:
Ability to provide approved written informed consent and complies with study-related procedures/assessments for the full duration of the study, having age ≥18 years.
Type 1 or Type 2 Diabetes Mellitus.
Proliferative Diabetic Retinopathy (level 61, 65, 71, or 75) in one or both eyes without evidence of significant vitreous/pre retinal hemorrhage that would limit photographic documentation of area of neovascularization and without pre-retinal fibrosis. If both eyes meet eligibility requirements, the less affected eye will be selected to receive investigational drug or placebo. The second eye will be treated with the standard of care. (e.g. panretinal laser photocoagulation).
Best-Corrected Visual acuity of 20/200 or better in each eye.

Key exclusion criteria (28 listed)

Male or female patients diagnosed with Proliferative Diabetic Retinopathy will not be eligible in the study if any of the exclusion criteria are met:
Clinically significant systemic diseases/conditions that, in the opinion of the Investigator, could negatively affect the safety of the patient during the study on a as determined on a case by case basis (e.g., unstable medical status including uncontrolled blood pressure, cardiovascular disease, uncontrolled liver disease, glycemic control or significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant, hepatic, pulmonary, gastrointestinal or neurological diseases, cancer or BMI).
Participation in any other clinical study/trial within the past 30 days prior to randomization.
Current treatment for active systemic infection.
Known allergy to any component of the formulation or to topical anesthetics (e.g., benzalkonium chloride, fluorescein, etc.).

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
2% OC-10XAlso: 2-Biphenyl-4-yl-2,3-dihydro-(1H)-quinazolin-4-one2% OC-10X	Drug	2% OC-10X
Placebo ComparatorAlso: PlaceboPlacebo	Drug	Placebo

Primary outcome

The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of neovascularization elsewhere in the retina (NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of neovascularization elsewhere in the retina (NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of "Posterior NVE" from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area change of area of "Posterior NVE" from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.

12 secondary outcomes

Change from baseline of regression of intraretinal microvascular abnormalities (IRMA) in PDR patients as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of intraretinal hemorrhage as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of area of capillary non-perfusion beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of intraretinal exudation (lipid) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of macular edema (central subfield thickness) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of macular volume as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of best-corrected ETDRS visual acuity as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of macular thickness as measured by Optical Coherence Tomography (OCT) compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Number of patients requiring rescue treatment at the end of the study.
Time frame: Baseline - 24 weeks
Number of patients requiring pars plana vitrectomy surgery due to presence of vitreous hemorrhage at the end of the study.
Time frame: Baseline - 24 weeks
Number of patients requiring pars plana vitrectomy surgery due to traction retinal detachment at the end of the study.
Time frame: Baseline - 24 weeks

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Individual participant dataSharing planned: Undecided

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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.

Patricia B Williams, PhD study director

OcuCure Therapeutics, Inc.

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 2% OC-10X in people with Proliferative Diabetic Retinopathy (PDR), run by OcuCure Therapeutics, Inc. at 1 site in Bangladesh.

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 10 inclusion and 28 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 5 Apr 2017. 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 Bangladesh. 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. Some participants in this study may receive a placebo. 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. 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?

The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. (time frame: Baseline - 24 weeks). 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 NCT02735369.

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 5 Apr 2017.