Retina Associates - Research Coordinators
 
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Study Detail: Denali

Trial Description

Summary:  A study comparing Lucentis injections alone versus Lucentis injections with Photodynamic Laser Treatment/ Visudyne in the treatment of Choroidal Neovascularization ("wet AMD") secondary to Age-Related Macular Degeneration.

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

IIIB

Subfoveal CNV (wet AMD) due to AMD

Enrolling

50 years or older

Novartis

CBPB952A2308

Study Duration: 24 months

Eligibility Criteria:

Inclusion Criteria-

· Primary or active Subfoveal CNV from AMD- predominantly classic, minimally classic and occult are acceptable.  Minimally classic and occult must have evidence of recent progression

1. SRH associated with CNV  OR

2. Increase of ≥10% increase in GDL compared to FA done within 3 months of screening OR

3. Loss of ≥5 letters (ETDRS) or 2 Snellen lines within 3 months of screening

· Total area of CNV must be ≥50% of total lesion area

· Total lesion area must have the GLD 5400 μm

· Va approx. 20/40 – 20/320 Snellen (73-24 BCVA letters)

· For additional information- see study coordinator

 Exclusion Criteria-

· Prior PDT, Subfoveal focal laser, submacular surgery, TTT, external-beam radiation

· Prior tx with Macugen, Lucentis, Avastin or other anti-angiogenic agents like Ruboxistaurin, Anecortave Acetate, Squalamine, SIRNA, VEGF-Trap etc.

· Fellow eye treatment with those meds listed above is permitted if administered > 30 days before screening.

· Presence of fibrosis, heme, PED or other hypo fluorescent lesions obscuring >50% of the CNV

· Uncontrolled glaucoma in SE (IOP ≥25 despite tx with 2 or more meds)

· Hx of intraocular surgery within 60 days prior to screening (except for uncomplicated CE)

· Hx of YAG capsulotomy in the SE within 30 days prior to screening

· Presence of angioid streaks, presumed ocular histo, pathologic myopia (>8 D or evidence of posterior segment abnormalities assoc. with pathologic myopia) or any other reason for CNV

· Tear or rip of RPE

· Active or hx of ocular inflammation or infection in the SE within the last 30 days

Any concurrent ocular condition in the SE that may lead to vision loss during the study

 

Study Title :  A 24-month randomized, double-masked, controlled, multicenter, phase IIIB study assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered in conjunction with ranibizumab (Lucentis™) monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Trial Contact Information

Site

Study Coordinator

Beachwood

Diane W., RN  216-831-5704 ext. 6800