Phase 2
N=20
Treatment of Corneal Neovascularization With Topical Pazopanib
Corneal Neovascularization
Bottom Line
View on ClinicalTrials.gov: NCT01257750 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Heart Rate — 68.7 Beats per Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pazopanib (5mg/ml) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reza Dana, MD
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate |
68.7 | — |
| PRIMARY Mean Arterial Pressure |
90.7 | — |
| PRIMARY Central Corneal Thickness |
590 | — |
| PRIMARY Intaocular Pressure |
16.9 | — |
| SECONDARY Corneal Neovascular Area |
1.5 | — |
| SECONDARY Corneal Invasion Area |
3.9 | — |
| SECONDARY Corneal Vessel Length |
38.0 | — |
| SECONDARY Corneal Vessel Caliber |
0.0003 | — |
Summary
The purpose of this study is to determine the safety and efficacy of a drug [Pazopanib (Votrient)] as a treatment for corneal neovascularization. The cornea is the clear, central portion of the eye and neovascularization means blood vessel growth. The cornea is typically avascular, or without blood vessels. Corneal neovascularization in the cornea and can put vision at risk. Numerous diseases of the cornea such as inflammation, ischemia (restriction of blood supply), infection, degeneration (or deterioration), trauma, or corneal stem cell deficiency can lead to corneal neovascularization. This major ocular complication can lead to corneal scarring, edema (swelling), lipid deposits, and inflammation that may significantly alter your vision. In addition, it worsens the outcome of potential future treatments, such as a corneal transplant. A corneal transplant is a treatment that many patients with severe corneal disease may ultimately need.
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent
- Ability to comply with study assessments and study requirements (for example, able to open the eye drop foil-wrap packaging and eye drop vials, willing to adhere to the daily dosing schedule) for the full duration of study
- Age > 18 years
- Patients with superficial or deep corneal neovascularization that extends farther than 1 mm from the limbus
- Patients are in stable overall health
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin ≤ 1.5x upper limit of normal (ULN) or isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin 1mm and ≥14 days duration) within 2 weeks prior to study entry
- Intravitreal or periocular steroids within 4 weeks prior to study entry
- Change in dose/frequency of topical steroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study entry
- Poorly controlled Hypertension: systolic blood pressure (BP) > 150 or diastolic BP > 90
- Medical history of uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) >7%
- Women 45 years of age or younger that are of child bearing potential as defined by:
- No history of a hysterectomy
- No history of a bilateral oophorectomy (ovariectomy)
- No history of a bilateral tubal ligation
- Not post-menopausal
- Subjects using hormone replacement therapy (HRT) that have experienced total cessation of menses for ≤ 1 year, OR, in questionable cases, have a follicle stimulating hormone (FSH) value 40pg/mL (>140 pmol/L) OR have documented evidence OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT. Signs of current infection, including fever and current treatment with antibiotics
- Participation in another simultaneous medical investigation or trial STUDY
Data sourced from ClinicalTrials.gov (NCT01257750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.