We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study) (LAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115556
First Posted: May 4, 2010
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Vitreous -Retina- Macula Consultants of New York
Results First Submitted: August 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Age Related Macular Degeneration
Intervention: Drug: Ranibizumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lucentis 2.0 mg Lucentis (ranibizumab) 2.0 mg
Lucentis 0.5 mg Lucentis (ranibizumab) 0.5 mg

Participant Flow:   Overall Study
    Lucentis 2.0 mg   Lucentis 0.5 mg
STARTED   7   2 
COMPLETED   7   2 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lucentis 2.0 mg Lucentis (ranibizumab) 2.0 mg
Lucentis 0.5 mg Lucentis (ranibizumab) 0.5 mg
Total Total of all reporting groups

Baseline Measures
   Lucentis 2.0 mg   Lucentis 0.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   2   9 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
 80.1  (5.4)   88.0  (0.0)   82.0  (5.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  71.4%      1  50.0%      6  66.7% 
Male      2  28.6%      1  50.0%      3  33.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Visual Acuity (VA) From Baseline at Month 6   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Mean Change in Visual Acuity (VA) From Baseline at Month 12   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: K. Bailey Freund, MD (or Galyna Ganieva, Research Manager)
Organization: Vitreous Retina Macula Consultants of New York
phone: 212-861-9797 ext 6929
e-mail: gganieva@vrmny.com



Responsible Party: Vitreous -Retina- Macula Consultants of New York
ClinicalTrials.gov Identifier: NCT01115556     History of Changes
Other Study ID Numbers: FVF4836S
First Submitted: April 30, 2010
First Posted: May 4, 2010
Results First Submitted: August 7, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017