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Proliferative Diabetic Retinopathy (PDR)Phase 1NCT01869933

Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study is intended to evaluate the safety and tolerability of topical OC-10X Ophthalmic Suspension in healthy human subjects. 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Proliferative Diabetic Retinopathy (PDR)
What is being tested?
OC-10X
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBangladesh
Study dates
Apr 2013to Jun 2013
Phase
Phase 1
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ability to provide approved written informed consent and comply with study-related procedures/assessments for the duration of the study, age > 18 years
  • Corrected visual acuity >20/25 in both eyes
  • IOP <21 mm Hg, with a difference between eyes of < 4 mm Hg
  • Ability to tolerate and self-administer vehicle eye drops.
  • Tolerance of a commercially available non-preserved, artificial tear solution
  • Normal slit lamp exam and dilated fundoscopic exam within one week previous to dosing
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  • Normal clinical laboratory profiles for complete blood count, serum chemistry and electrolytes, and urinalysis with no clinically significant values
  • Be neither overweight nor underweight for his/her height as per BMI scale (18.5-24.9)
  • Female of childbearing potential:
  • Is practicing an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, IUD, or abstinence; or
  • Is postmenopausal for at least 1 year; or
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Who cannot join

  • Evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
  • History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematological disease, diabetes, glaucoma, head-injury or coma
  • History of significant recurrent bacterial, viral or fungal infections
  • History of any psychiatric illness, which may impair the ability to provide written informed consent
  • Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection
  • Presence of values which are significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential white blood cell count or platelet count
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  • Positive urinary screen testing of drugs of abuse (opiates, cannabinoids, amphetamines, barbiturates, benzodiazepines, cocaine)
  • Presence of values, which are significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase, serum alanine aminotransferase, serum alkaline phosphatase, serum bilirubin, plasma glucose, serum cholesterol, serum electrolytes (sodium, potassium, chloride, calcium and phosphorus),serum proteins (albumin and globulin) and serum creatinine phosphokinase
  • Clinically abnormal chemical and microscopic examination of urine defined as presence of red blood cells, white blood cells (>4/High Power Field [HPF]), glucose (positive) or protein (positive)
  • Clinically abnormal electrocardiogram
  • Regular smokers, who smoke more than 10 cigarettes daily, or have difficulty abstaining from smoking
  • 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 from drinking
  • Subjects who, through completion of this study, would have donated and/or lost more than 400 mL of blood in past 2 months
  • History of ocular surgery, trauma, or chronic ocular disease
  • Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day
  • Any ocular abnormalities or ocular symptoms
  • Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period
  • Systemic corticosteroid use within the past 6 months
  • History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis
  • Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding.
  • Use of antimitotic or antimetabolite therapy within 2 months of enrollment.
  • Women who are pregnant or breastfeeding, or nonsterile or premenopausal women who refuse to use any form of contraception during and for at least 2 weeks following the final dose of study drug.
  • Enrollment in another investigational drug or device study within 2 months of study entry.
  • Known intolerance or hypersensitivity to any components/excipients in the study drug formulation.
  • Planned use during the study of any ocular or systemic medication, with the exception of oral contraceptives and short-term use of over-the-counter analgesics.

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: An Open Label Phase I Placebo Controlled, Dose Escalation Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X

The present study is intended to evaluate the safety and tolerability of topical OC-10X Ophthalmic Suspension in healthy human subjects. 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 demonstrated both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of AMD. 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 has promise as a new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years or more. If administration of OC-10X is well tolerated as a topical eye drop and is well tolerated systemically, then OC-10X will have the potential to provide benefits to patients with ocular diseases associated with angiogenesis.

Being tested
OC-10X
Keywords
Proliferative, Diabetic, Retinopathy
Medical subject headings
Retinal Diseases

What participants receive

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

  • OC-10XDrug

Study groups in NCT01869933
Study groupRoleWhat they receive
1% OC-10XExperimentalSubjects selected to Cohort I will receive active 1% OC-10X in OD (Oculus Dexter - right eye) and placebo (vehicle) in OS (Oculus Sinister - left eye) in the Period 1 dosing. On Study Day 1 the subjects will have a drop instilled in each eye by personnel at study hours 0, 3, 6 and 9, and be evaluated frequently throughout the day. Subjects will be examined on Study Day 2 (24 hours after first dose). On Study Day 3 (48 hours after the first dose), these subjects will commence Period 2 dosing, with the active (OD) or placebo (OS). Dosing will continue q.i.d. for an additional 13 days.
Receives: Drug: OC-10X
2% OC-10XExperimentalSubjects selected to Cohort II will receive active 2% OC-10X in OD (Oculus Dexter - right eye) and placebo (vehicle) in OS (Oculus Sinister - left eye) in the Period 1 dosing. On Study Day 1 the subjects will have a drop instilled in each eye by personnel at study hours 0, 3, 6 and 9, and be evaluated frequently throughout the day. Subjects will be examined on Study Day 2 (24 hours after first dose). On Study Day 3 (48 hours after the first dose), these subjects will commence Period 2 dosing, with the active (OD) or placebo (OS). Dosing will continue q.i.d. for an additional 13 days.
Receives: Drug: OC-10X

What is being measured

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

  1. Ocular Safety and Tolerability

    Ocular safety and tolerability will be assessed by subject query, biomicroscopy of anterior segment, ophthalmoscopy, measuring intraocular pressure (IOP) and checking visual acuity by modified Early Treatment Diabetic Retinopathy Study (ETDRS).

    Measured: 17 Days

Secondary outcomes (1)

  1. Systemic Safety and Tolerability

    Systemic safety and tolerability will be examined by checking vital signs including heart rate, blood pressure, body temperature and respiratory rate, by electrocardiography (ECG) and performing a physical exam. Normal systemic function will be examined by routine blood draw for clinical chemistry, complete blood chemistry (CBC) and measure of plasma concentration of OC-10X.

    Measured: 17 Days

Timeline

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

  1. First posted5 Jun 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01869933
Sponsor's protocol ID
OC-10X-102
Status last verified
Jan 2016
First submitted
28 May 2013
Last updated
22 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 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 12 inclusion and 25 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: finished, as of the sponsor's last update on 22 Jan 2016. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ocular Safety and Tolerability (time frame: 17 Days). 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 NCT01869933.

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 22 Jan 2016.

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