Combretastatin A4 Phosphate in Patients With Neovascular Age-Related Macular Degeneration

Completed · Phase 1/Phase 2

Conditions studied: Combretastatin A4 Phosphate, Age-related Macular Degeneration, AMD, CNV, Choroidal Neovascularization

In brief

The purpose of the study is assess safety, bioactivity, and maximal tolerated dose of repeated weekly intravenous infusion of combretastatin A-4 phosphate (CA4P) in patients with neovascular age-related macular degeneration

Key facts

Study ID

NCT01570790

Run by

Johns Hopkins University

People needed

8

Starts

2003-05-01

Expected to finish

2005-06-01

Last updated by the study team

2017-12-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 50 years or older;
• 12-lead electrocardiogram (ECG) performed at least 2 weeks but less than 4 weeks prior to entry into the study showing a QTc <440 with no evidence of current or prior myocardial ischemia, infarction or significant arrhythmia as determined by review and signature of the cardiologist.
• Adequate bone marrow function:
• Absolute granulocyte count ≥1500 cells/mm3; Platelet count ≥100,000 cells/mm3; Hemoglobin ≥9.0gm/ dL;
• PT/PTT within the institution upper limit of normal (ULN) or INR <1.1 ;
• Adequate hepatic function:
• Total bilirubin within the institution ULN; Alanine and aspartate aminotransferase (ALT/AST) <3 times the institutional ULN;
• Adequate renal function: serum creatinine ≤2.0 mg/dL;
• Ophthalmic criteria:
• Best corrected visual acuity in the study eye of ≤20/40 and ≥20/800 in the fellow eye.
• Subfoveal choroidal neovascularization (as illustrated by fluorescein angiography) secondary to age-related macular degeneration, with a total lesion size of ≤12 total disc areas, of which at least 50% must be active CNV.
• Subretinal hemorrhage ≤50% of total lesion size;
• For patients with minimally classic and purely occult CNV, there must be documented evidence of ≥2 lines of vision loss (ETDRS) during the previous 12 weeks;
• Clear ocular media and adequate papillary dilatation to permit good quality stereoscopic fundus photography;
• Male fertile patients must abstain from sexual intercourse or use effective birth control;
• Women must be post-menopausal for at least 12 months prior to study entry, or surgically sterile, or must be using two forms of effective contraception.
• Able to return for all study visits within required visit windows;
• Be able to give written informed consent.

You may not qualify if…

• Previous subfoveal thermal laser therapy;
• Any subfoveal scarring or atrophy, or >25% of the total lesion size is made up of scarring or atrophy;
• Significant media opacities, including cataract, which can interfere with visual acuity, assessment of toxicity, or fundus photography;
• Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of ≥-8.0 diopters, or axial length of ≥25mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis and other uveitic entities;
• Any condition that might interfere with assessment of the progression of CNV;
• Any intraocular surgery in the study eye within 12 weeks of screening for the study;
• Other treatment for AMD of the study eye within 12 weeks prior to screening;
• Known allergy to fluorescein;
• Any current or history of significant gastrointestinal, oral, or nasal bleeding;
• Serious intercurrent infections or other nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy;
• Grade 2 (CTC v.3.0) or greater pre-existing peripheral neuropathy;
• Psychiatric disorders or other conditions rendering patients incapable of complying with the requirements of the protocol;
• Pregnant or breast-feeding women;
• History of angina, myocardial infarction, CHF, non-controlled atrial arrhythmias or clinically significant arrhythmias including conduction abnormality, nodal junctional arrhythmias and dysrhythmias, sinus bradycardia or tachycardia, supraventricular arrhythmias, atrial fibrillation or flutter, syncope or vasovagal episodes;
• Abnormal cardiac stress test;
• Uncontrolled hypertension (consistently >150/100mmHg irrespective of medication);
• Uncontrolled hypokalemia and/or hypomagnesemia;
• ECG with evidence of prior myocardial infarction, QTc > 450 msec or other clinically significant abnormalities;
• Drug(s) known to prolong the QTc interval;
• Patients with conditions associated with QTc prolongation;
• Any investigational drug or device within 4 weeks prior to screening;
• Decreased ejection fraction ≤50% or prior myocardial infarction.

Where it is running

• Wilmer Eye Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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