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A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration

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.
 
ClinicalTrials.gov Identifier: NCT00395057
Recruitment Status : Terminated (The study was terminated early due to company decision (non-safety related).)
First Posted : November 2, 2006
Results First Posted : December 13, 2011
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Choroid Neovascularization
Age-Related Macular Degeneration
Interventions Drug: AGN 211745
Drug: Ranibizumab 500µg
Enrollment 138
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Period Title: Overall Study
Started 34 35 35 34
Completed 2 1 2 1
Not Completed 32 34 33 33
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug Total
Hide Arm/Group Description AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug Total of all reporting groups
Overall Number of Baseline Participants 34 35 35 34 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 35 participants 34 participants 138 participants
Between 45 and 65 years 2 5 5 4 16
>=65 years 32 30 30 30 122
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 35 participants 34 participants 138 participants
Female
19
  55.9%
19
  54.3%
24
  68.6%
14
  41.2%
76
  55.1%
Male
15
  44.1%
16
  45.7%
11
  31.4%
20
  58.8%
62
  44.9%
1.Primary Outcome
Title Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
Hide Description Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description:
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Overall Number of Participants Analyzed 34 35 35 34
Measure Type: Number
Unit of Measure: Percentage of Patients
5.9 2.9 0 17.6
2.Secondary Outcome
Title Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3
Hide Description Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat. The ITT population included all patients who started the study (randomized).
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description:
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Overall Number of Participants Analyzed 34 35 35 34
Mean (Standard Deviation)
Unit of Measure: Millimeters squared (mm^2)
6.17  (4.339) 4.29  (3.264) 6.54  (6.102) 3.89  (3.396)
3.Secondary Outcome
Title Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3
Hide Description Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description:
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Overall Number of Participants Analyzed 34 35 35 34
Mean (Standard Deviation)
Unit of Measure: Microns
484.6  (142.21) 413.2  (103.59) 437.1  (125.46) 269.8  (76.72)
4.Secondary Outcome
Title Visual Functioning Questionnaire (VFQ) at Month 3
Hide Description Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early.
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description:
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Treatment With Standard of Care at Month 6
Hide Description Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description:
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Overall Number of Participants Analyzed 34 35 35 34
Median (95% Confidence Interval)
Unit of Measure: Number of Days
91.0
(86.00 to 102.0)
91.5
(90.00 to 119.0)
92.0
(91.00 to 112.0)
130.5
(96.00 to 161.0)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
 
Arm/Group Title AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Hide Arm/Group Description AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
All-Cause Mortality
AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/34 (11.76%)   3/35 (8.57%)   3/35 (8.57%)   9/34 (26.47%) 
Cardiac disorders         
Angina pectoris  1  0/34 (0.00%)  1/35 (2.86%)  0/35 (0.00%)  1/34 (2.94%) 
Gastrointestinal disorders         
Inguinal hernia  1  0/34 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Small intestinal obstruction  1  0/34 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Hepatobiliary disorders         
Biliary tract disorder  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Cholelithiasis  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Infections and infestations         
Pneumonia  1  0/34 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Herpes zoster ophthalmic  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Pneumonia legionella  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Metabolism and nutrition disorders         
Dehydration  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Chronic lymphocytic leukaemia  1  1/34 (2.94%)  0/35 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Leukaemia  1  1/34 (2.94%)  0/35 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Lip neoplasm malignant stage unspecified  1  1/34 (2.94%)  0/35 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Basal cell carcinoma  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Non-small cell lung cancer  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Nervous system disorders         
Syncope  1  0/34 (0.00%)  1/35 (2.86%)  0/35 (0.00%)  0/34 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  0/34 (0.00%)  1/35 (2.86%)  0/35 (0.00%)  0/34 (0.00%) 
Vascular disorders         
Peripheral ischaemia  1  1/34 (2.94%)  0/35 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Hypertension  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AGN 211745 Solution 1000 ug AGN 211745 Solution 300 ug AGN 211745 Solution 100 ug Ranibizumab 500 ug
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/34 (85.29%)   26/35 (74.29%)   28/35 (80.00%)   24/34 (70.59%) 
Cardiac disorders         
Angina pectoris  1  0/34 (0.00%)  1/35 (2.86%)  0/35 (0.00%)  2/34 (5.88%) 
Eye disorders         
Conjunctival haemorrhage * 1  10/34 (29.41%)  9/35 (25.71%)  12/35 (34.29%)  5/34 (14.71%) 
Retinal haemorrhage  1  5/34 (14.71%)  2/35 (5.71%)  2/35 (5.71%)  3/34 (8.82%) 
Eye Pain * 1  3/34 (8.82%)  9/35 (25.71%)  5/35 (14.29%)  1/34 (2.94%) 
Anterior chamber cell  1  3/34 (8.82%)  2/35 (5.71%)  1/35 (2.86%)  1/34 (2.94%) 
Conjunctival oedema  1  3/34 (8.82%)  0/35 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Lacrimation increased * 1  2/34 (5.88%)  4/35 (11.43%)  2/35 (5.71%)  3/34 (8.82%) 
Vitreous floaters  1  2/34 (5.88%)  2/35 (5.71%)  5/35 (14.29%)  0/34 (0.00%) 
Conjunctival hyperaemia  1  2/34 (5.88%)  2/35 (5.71%)  4/35 (11.43%)  2/34 (5.88%) 
Detachment of retinal pigment  1  2/34 (5.88%)  5/35 (14.29%)  1/35 (2.86%)  2/34 (5.88%) 
Ocular discomfort * 1  2/34 (5.88%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Retinal neovascularization  1  2/34 (5.88%)  0/35 (0.00%)  0/35 (0.00%)  1/34 (2.94%) 
Retinal exudates  1  2/34 (5.88%)  0/35 (0.00%)  0/35 (0.00%)  0/34 (0.00%) 
Foreign body sensation in eyes * 1  1/34 (2.94%)  5/35 (14.29%)  0/35 (0.00%)  1/34 (2.94%) 
Anterior chamber flare  1  1/34 (2.94%)  2/35 (5.71%)  0/35 (0.00%)  1/34 (2.94%) 
Retinal oedema  1  1/34 (2.94%)  1/35 (2.86%)  2/35 (5.71%)  3/34 (8.82%) 
Macular degeneration  1  1/34 (2.94%)  0/35 (0.00%)  1/35 (2.86%)  2/34 (5.88%) 
Vitreous detachment  1  0/34 (0.00%)  4/35 (11.43%)  1/35 (2.86%)  1/34 (2.94%) 
Vision blurred * 1  0/34 (0.00%)  3/35 (8.57%)  2/35 (5.71%)  1/34 (2.94%) 
Eye irritation * 1  0/34 (0.00%)  2/35 (5.71%)  3/35 (8.57%)  1/34 (2.94%) 
Blepharitis * 1  0/34 (0.00%)  2/35 (5.71%)  1/35 (2.86%)  1/34 (2.94%) 
Eye discharge * 1  0/34 (0.00%)  2/35 (5.71%)  0/35 (0.00%)  0/34 (0.00%) 
Punctate keratitis  1  0/34 (0.00%)  1/35 (2.86%)  2/35 (5.71%)  1/34 (2.94%) 
Retinal pigment epitheliopathy  1  0/34 (0.00%)  0/35 (0.00%)  1/35 (2.86%)  3/34 (8.82%) 
Gastrointestinal disorders         
Diarrhoea * 1  1/34 (2.94%)  0/35 (0.00%)  2/35 (5.71%)  0/34 (0.00%) 
Hiatus hernia  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  2/34 (5.88%) 
Hepatobiliary disorders         
Cholelithiasis  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  2/34 (5.88%) 
Infections and infestations         
Urinary tract infection  1  3/34 (8.82%)  2/35 (5.71%)  4/35 (11.43%)  1/34 (2.94%) 
Upper respiratory tract infection  1  1/34 (2.94%)  0/35 (0.00%)  2/35 (5.71%)  3/34 (8.82%) 
Pneumonia  1  0/34 (0.00%)  0/35 (0.00%)  2/35 (5.71%)  1/34 (2.94%) 
Injury, poisoning and procedural complications         
Corneal abrasion  1  1/34 (2.94%)  1/35 (2.86%)  2/35 (5.71%)  3/34 (8.82%) 
Investigations         
Alanine aminotransferase increased  1  0/34 (0.00%)  0/35 (0.00%)  0/35 (0.00%)  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/34 (0.00%)  0/35 (0.00%)  2/35 (5.71%)  0/34 (0.00%) 
Nervous system disorders         
Headache * 1  0/34 (0.00%)  1/35 (2.86%)  1/35 (2.86%)  2/34 (5.88%) 
Psychiatric disorders         
Insomnia * 1  0/34 (0.00%)  2/35 (5.71%)  0/35 (0.00%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  2/34 (5.88%)  0/35 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Epistaxis * 1  2/34 (5.88%)  0/35 (0.00%)  1/35 (2.86%)  0/34 (0.00%) 
Vascular disorders         
Hypertension  1  0/34 (0.00%)  0/35 (0.00%)  3/35 (8.57%)  1/34 (2.94%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
The study was terminated early due to a company decision (non-safety related). Because the study was terminated early, data for certain outcome measures (ie, "Visual Functioning Questionnaire [VFQ] at Month 3") were not analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00395057    
Other Study ID Numbers: 211745-001
First Submitted: October 31, 2006
First Posted: November 2, 2006
Results First Submitted: November 9, 2011
Results First Posted: December 13, 2011
Last Update Posted: September 7, 2015