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

NCT01869933 | Completed Phase 1 DMC

• 1 other identifier: OC-10X-102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Proliferative Diabetic Retinopathy (PDR)

Keywords

Proliferative, Diabetic, Retinopathy

Outcome Measures

Primary Outcomes (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).

  17 Days

Secondary Outcomes (1)

• Systemic Safety and Tolerability

  17 Days

Study Arms (2)

1% OC-10X

EXPERIMENTAL

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.

Drug: OC-10X

2% OC-10X

EXPERIMENTAL

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.

Drug: OC-10X

Interventions

OC-10X DRUG

1% OC-10X; 2% OC-10X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• OcuCure Therapeutics, Inc.: lead

Study Sites (1)

Bangladesh Eye Hospital

Dhaka, 1205, Bangladesh

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Dr Niaz Abdur-Rahman, MBBS,DO,MPH

  Bangladesh Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 5, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

BA (1)