I/E Criteria
This DME study requires CST greater than or equal to 325 microns and excludes high-risk PDR in the SE
What is ALTO (Kodiak)
This study investigates an oral plasma plasma kallikrein inhibitor designed to reduce retinal edema & vascular hyperpermeability.
What is THULITE (BI)
(BI 1815368)
When a site receives a CDA from a sponsor/ CRO, it should be sent to this department.
What is RCA Research BD
What is HELIOS 3 (Ocular Therapeutics)
These two documents are required and should be uploaded to the Documents section for all site opportunities to ensure complete documentation.
What are FQ and SSL
This wet AMD study requires patients to be pseudophakic and have received at least two anti-VEGF injections in the previous six months.
What is ACHIEVE (AbbVie)
This GA study investigates a first-in-class IVT therapy that inhibits the Fas receptor, aiming to reduce Fas-mediated cell death and provide neuroprotection.
What is GALAXY (ONL Therapeutics)
BD's least favorite plot twist: a site clears feasibility and selection, only to perform this action before enrollment begins.
What is withdrawing from the study
Kodiak's ALTO study requires a washout period of this duration for both for Anti-VEGF therapies and Ozurdex prior to Day 1.
What is 12 weeks (90 days)
Sites are expected to respond to study interest inquiries within this timeframe.
What is 48 business hours
In this DME study, treatment-naive patients have to be diagnosed within 9 months, while previously treated patients are required to have started treatment within the prior 3 years.
What is SANGIOVESE/ SYRAH (Merck)
This study evaluates a subretinal gene therapy utilizing an AAV8 vector that encodes a soluble anti-VEGF Fab protein to provide sustained anti-VEGF activity.
What is ACHIEVE (AbbVie)
A site says, "We can enroll 20 patients!" During startup they discover they can enroll two. This process was likely not completed accurately.
What is the 'feasibility questionnaire"
The FE of this study can only be treated with this Aflibercept at investigator discretion.
What is HYACINTH (Amgen)
All unanswered site interest requests are housed here for review and follow-up.
Where is Site 'Dashboard'
This NPDR study enrolls patients with DRSS scores of 47 or 53 and the SE can be either treatment naive or previously treated.
What is HELIOS 3 (Ocular Therapeutics)
This study's MOA has a bispecific antibody that both inhibits VEGF and activates Tie2 to stabilize retinal/ choroidal blood vessels.
What is SANGIOVESE/ SYRAH (Merck)
(Tiespectus)(MK-8748)
The RCA Research's BD team email.
In Merck's SANGIOVESE/ SYRAH studies, patients previously treated with Eylea HD or Vabysmo are required to complete this washout period before the screening visit.
What is 120 Days
The first place to reference for all study-related updates and communications from the BD and BCT teams.
What is 'Progress Notes'
This GA study allows for non-subfoveal lesions only between 2.125 mm2 and 20.125 mm2 that are non-contiguous with PPA.
What is GALAXY (ONL Therapeutics)
This study uses a long-acting bispecific trap-antibody that inhibits VEGF and IL-6, demonstrating an extended ocular half-life.
What is ALTO (Kodiak)
(Tabirafusp tedromer) (KSI-501)
Not all randomizations are created equal. A study must generate at least this amount per participant to qualify toward a site's budget randomization goal.
What is $10,000
To remain eligible for randomization, participants in 4DMT's 4SIGHT study can not lose more than this many ETDRS letters during the run-in period.
What is 15 ETDRS letters
This is the central repository for master CDAs, accessible to all authorized users.
What is 'Accounts'