Design Module

Design Module

The Design Module contains detailed information about the study design, including study type, allocation methods, intervention models, masking information, primary purpose, enrollment details, and biospecimen information. This module provides essential details about how the clinical trial is structured and conducted.

Design Module path is as follows:

Study -> Protocol Section -> Design Module

Design Module


Ignite Creation Date: 2025-12-24 @ 11:28 PM
Ignite Modification Date: 2025-12-24 @ 11:28 PM
NCT ID: NCT04108156
Study Type: INTERVENTIONAL
Allocation: RANDOMIZED
Primary Purpose: TREATMENT
Study: NCT04108156
Study Brief: A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Protocol Section: NCT04108156
Bio Specs (If Any):
Design Masking Infos (If Any):

Design Masking Infos

Design Masking Brief View
None View
Design Observational Models (If Any):
Design Time Perspectives (If Any):
Design Who Masked (If Any):
Enrollment Infos (If Any):

Enrollment Infos

Enrollment Type Enrollment Count View
ESTIMATED 634 View
Expanded Access Types (If Any):
Phases (If Any):

Phases

Phase Brief Phase Text View
None PHASE3 View