PER-099-07
Completed
未知
A STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF FOCAL EPIRETINAL RADIOTHERAPY AND RANIBIZUMAB (LUCENTIS®) FOR THE TREATMENT OF SUBFOVEAL CHOROIDAL NEOVASCULARIZATION (CNV) SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD)
EOVISTA INC.,0 sites0 target enrollmentApril 1, 2008
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -H31
- Sponsor
- EOVISTA INC.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of \< 12 total disc areas (21\.24 mm^), and a GLD \<5\.4 mm;
- •Lesions may be primary (newly diagnosed and untreated) or recurrent (previously diagnosed and regressed but currently presenting with a new, active component);
- •Subjects must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye a) Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse acuity will be selected for treatment and study. If only one eye is eligible, vision in the non\-study eye must be 20/400 or better;
- •Subretinal heme (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space;
- •Minimally classic and occult with no classic lesions must have evidence of presumed recent disease progression defined as: a. The presence of subretinal hemorrhage and/or fluid and/or lipid OR b. Loss of one or more lines of vision (ETDRS or equivalent) during the past six months OR c. FA documented lesion growth by \> 10% during the past 6 months;
- •Subjects must be age 50 or older;
- •Subjects must be willing and able to return for scheduled treatment and follow\-up examinations for three years;
- •Women must be post\-menopausal \>1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days prior to randomization.
Exclusion Criteria
- •Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti\-angiogenic or intravitreal anti\-angiogenic agents in study eye.
- •Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection;
- •Subjects with advanced glaucoma (greater than 0\.8 cup:disk) or intraocular pressure \> 30 mmHg in the study eye;
- •Previous glaucoma filtering surgery in the study eye;
- •Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye,
- •Subjects with any subfoveal scarring, atrophy, or hemorrhage in the study
- •Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy; ^ ,
- •8 Subjects with inadequate pupillary dilation or significant media opacities in the study eye, including cataract, which may interfere with visual acuity or the evaluation of the posterior segment,
- •Current vitreous hemorrhage in the study eye,
- •History of rhegmatogenous retina detachment or macular hole in the study eye;
Outcomes
Primary Outcomes
Not specified
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