Other Clinical Trial - The TIME-2b Study: A Study of AKB-9778

The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR) — TIME-2b

Nonproliferative Diabetic Retinopathy Clinical Trial

Official title:
Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 (Razuprotafib)15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy

See also
Status	Clinical Trial	Phase
Completed	`NCT02718326` - Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)	Phase 3
Recruiting	`NCT05383209` - Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)	Phase 2
Completed	`NCT02834663` - Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy	Phase 4

See also

Status

Clinical Trial

Phase

Completed

NCT02718326 - Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

Phase 3

Recruiting

NCT05383209 - Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Phase 2

Completed

NCT02834663 - Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy

Phase 4

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03197870
Study type	Interventional
Source	EyePoint Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	June 9, 2017
Completion date	February 9, 2019

The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR) — TIME-2b

Clinical Trial Summary

Clinical Trial Description

Study Design

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