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

January 20, 2016 updated by: OcuCure Therapeutics, Inc.

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dhaka, Bangladesh, 1205
        • Bangladesh Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Ability to provide approved written informed consent and comply with study-related procedures/assessments for the duration of the study, age > 18 years
  2. Corrected visual acuity >20/25 in both eyes
  3. IOP <21 mm Hg, with a difference between eyes of < 4 mm Hg
  4. Ability to tolerate and self-administer vehicle eye drops.
  5. Tolerance of a commercially available non-preserved, artificial tear solution
  6. Normal slit lamp exam and dilated fundoscopic exam within one week previous to dosing
  7. Normal clinical laboratory profiles for complete blood count, serum chemistry and electrolytes, and urinalysis with no clinically significant values
  8. Be neither overweight nor underweight for his/her height as per BMI scale (18.5-24.9)
  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)

Exclusion Criteria

  1. Evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
  2. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematological disease, diabetes, glaucoma, head-injury or coma
  3. History of significant recurrent bacterial, viral or fungal infections
  4. History of any psychiatric illness, which may impair the ability to provide written informed consent
  5. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection
  6. 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
  7. Positive urinary screen testing of drugs of abuse (opiates, cannabinoids, amphetamines, barbiturates, benzodiazepines, cocaine)
  8. 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
  9. 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)
  10. Clinically abnormal electrocardiogram
  11. Regular smokers, who smoke more than 10 cigarettes daily, or have difficulty abstaining from smoking
  12. 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
  13. Subjects who, through completion of this study, would have donated and/or lost more than 400 mL of blood in past 2 months
  14. History of ocular surgery, trauma, or chronic ocular disease
  15. Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day
  16. Any ocular abnormalities or ocular symptoms
  17. Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period
  18. Systemic corticosteroid use within the past 6 months
  19. History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis
  20. Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding.
  21. Use of antimitotic or antimetabolite therapy within 2 months of enrollment.
  22. 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.
  23. Enrollment in another investigational drug or device study within 2 months of study entry.
  24. Known intolerance or hypersensitivity to any components/excipients in the study drug formulation.
  25. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1% OC-10X
Subjects 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.
Experimental: 2% OC-10X
Subjects 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Safety and Tolerability
Time Frame: 17 Days
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).
17 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic Safety and Tolerability
Time Frame: 17 Days
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.
17 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr Niaz Abdur-Rahman, MBBS,DO,MPH, Bangladesh Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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