Other Clinical Trial - Safety & Tolerability of Ranibizumab in

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye — TWEYES

Wet Age Related Macular Degeneration Clinical Trial

Official title:
A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01899963` - Time to Treatment Utilizing a Tele-Retinal Referral System for wAMD and DME: A Pilot Study
	Completed	`NCT01318941` - Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT01899963 - Time to Treatment Utilizing a Tele-Retinal Referral System for wAMD and DME: A Pilot Study

Completed

NCT01318941 - Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

N/A

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	NCT01986907
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	March 4, 2014
Completion date	June 15, 2016

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye — TWEYES

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms