Phase 2
N=24
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
PCV · Polypoidal Choroidal Vasculopathy
Bottom Line
View on ClinicalTrials.gov: NCT01884597 ↗Enrolled (actual)
24
Serious AEs
4.8%
Results posted
Sep 2017
Primary outcome: Primary: BCVA — -3.50; 29.50; 8.60 number of letters read correctly
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- high-dose ranibizumab (Drug); ranibizumab (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Hawaii Pacific Health
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BCVA |
55.00; 50.00; 62.80; 52.00; 52.50; 64.07 | — |
| PRIMARY BCVA |
55.00; 50.00; 62.80; 52.00; 52.50; 64.07 | — |
| SECONDARY Ocular Adverse Events (AE) |
0; 0; 0 | — |
| SECONDARY Systemic AEs |
0; 0; 1 | — |
| SECONDARY BCVA |
55.00; 50.00; 62.80; 52.00; 52.50; 64.07 | — |
| SECONDARY Macular Edema |
370.25; 347.50; 282.47; 265.00; 251.00; 235.07 | — |
| SECONDARY PCV Anatomic Changes |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Fundus Clinical Findings |
0; 0; 0; 1; 2; 8 | — |
Summary
This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 25 years
- Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- BCVA using ETDRS of 20/32 to 20/400
Exclusion Criteria
- Any history of previous vitrectomy
- Any prior treatment with verteporfin photodynamic therapy in the study eye.
- Previous cataract surgery within the preceding 2 months of Day 0
- Active intraocular inflammation in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease)
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Prior anti-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in the study eye prior within 30 days prior to enrollment in this study
- Known allergy to any component of the study drug
- Blood pressure >180/110 (systolic above 180 or diastolic above 110) If blood pressure if brought below 180/110 by anti-hypertensive treatment, the patient can become eligible.
- Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
- Myocardial infraction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
- History of recurrent significant infections or bacterial infections
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception, surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicide gel, an intra uterine device (IUD), or contraceptive hormone implant or patch
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial.
Data sourced from ClinicalTrials.gov (NCT01884597). 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.