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Re: DewDiligence post# 188043

Tuesday, 03/03/2015 10:44:45 AM

Tuesday, March 03, 2015 10:44:45 AM

Post# of 252209
You put links to Ophthotech's phase 3 trials showing that they not excluding occult patients, the problem is that if you go to their phase 2 trial is doesn't show them excluding occult patients either. It is only mentioned in the sec docs



from phase 2

https://clinicaltrials.gov/ct2/show/NCT01089517?term=ophthotech&rank=8

A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

Eligibility

Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria:

Any of the following underlying diseases including:

Diabetes mellitus
History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
Clinically significant impaired renal or hepatic function.
Stroke (within 12 months of trial entry).
Any major surgical procedure within one month of trial entry.
Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation

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