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An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

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ClinicalTrials.gov Identifier: NCT00661479
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Retinitis Pigmentosa
Interventions Drug: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant
Drug: 100 µg Brimonidine Tartrate Implant
Other: Sham (no implant)
Enrollment 21
Recruitment Details  
Pre-assignment Details Patients were stratified by Best Corrected Visual Acuity (BCVA). Patients assigned to Group A had a BCVA of 20/320. Patients assigned to Group B had a BCVA worse than 20/40 and better than 20/320. Patients in Group A were randomized and treated prior to initiating enrollment in Group B. No patients from Group A participated in Group B.
Arm/Group Title 400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group A
Hide Arm/Group Description 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Period Title: Overall Study
Started 12 3 3 3
Completed 12 3 3 3
Not Completed 0 0 0 0
Arm/Group Title 400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group A Total
Hide Arm/Group Description 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 12 3 3 3 21
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 3 participants 3 participants 3 participants 21 participants
46.3  (18.70) 56.3  (6.03) 48.7  (4.04) 69.0  (5.29) 51.3  (16.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 3 participants 3 participants 21 participants
Female
5
  41.7%
1
  33.3%
3
 100.0%
0
   0.0%
9
  42.9%
Male
7
  58.3%
2
  66.7%
0
   0.0%
3
 100.0%
12
  57.1%
1.Primary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Hide Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all patients treated on Day 1
Arm/Group Title 400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group A
Hide Arm/Group Description:
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Overall Number of Participants Analyzed 12 3 3 3
Mean (Standard Deviation)
Unit of Measure: Number of Letters Read Correctly
Baseline 48.5  (14.61) 51.0  (14.18) 52.7  (3.79) 4.0  (3.46)
Change from Baseline at Month 6 3.2  (4.41) -1.3  (4.04) 3.3  (8.50) 0.3  (3.79)
2.Secondary Outcome
Title Change From Baseline in Contrast Sensitivity in the Study Eye
Hide Description Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all patients treated on Day 1
Arm/Group Title 400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Group A
Hide Arm/Group Description:
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Overall Number of Participants Analyzed 12 3 3 3
Mean (Standard Deviation)
Unit of Measure: Number of Letters Read Correctly
Baseline 15.5  (8.48) 18.0  (7.21) 22.3  (1.53) 3.0  (3.46)
Change from Baseline at Month 6 0.8  (4.86) -0.3  (5.86) 4.3  (1.15) -2.0  (1.73)
Time Frame [Not Specified]
Adverse Event Reporting Description For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
 
Arm/Group Title 400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Groups A and B
Hide Arm/Group Description 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
All-Cause Mortality
400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Groups A and B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Groups A and B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   0/3 (0.00%)   1/6 (16.67%) 
Nervous system disorders       
Syncope * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Myelitis  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
400 µg Brimonidine Tartrate Implant Group B 200 µg Brimonidine Tartrate Implant Group B 100 µg Brimonidine Tartrate Implant Groups A and B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   3/3 (100.00%)   6/6 (100.00%) 
Congenital, familial and genetic disorders       
Colour Blindness * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Ear and labyrinth disorders       
Tinnitus * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Ear Pain * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Eye disorders       
Conjunctival Haemorrhage  1  5/12 (41.67%)  2/3 (66.67%)  1/6 (16.67%) 
Conjunctival Hyperaemia  1  5/12 (41.67%)  3/3 (100.00%)  5/6 (83.33%) 
Foreign Body Sensation in Eyes * 1  3/12 (25.00%)  0/3 (0.00%)  1/6 (16.67%) 
Ocular Discomfort * 1  3/12 (25.00%)  0/3 (0.00%)  1/6 (16.67%) 
Glare * 1  2/12 (16.67%)  0/3 (0.00%)  0/6 (0.00%) 
Eye Pain * 1  2/12 (16.67%)  0/3 (0.00%)  2/6 (33.33%) 
Conjunctival Oedema * 1  2/12 (16.67%)  2/3 (66.67%)  1/6 (16.67%) 
Conjunctivitis Allergic * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Dry Eye * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Eye Irritation * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Lacrimation Increased * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Vision Blurred * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Visual Disturbance * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Abnormal Sensation in Eye * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Keratitis  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Visual Acuity Reduced  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Vitreous Floaters * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Conjunctivitis  1  0/12 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Gastrointestinal disorders       
Nausea * 1  2/12 (16.67%)  0/3 (0.00%)  0/6 (0.00%) 
Abdominal pain * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Abdominal Pain Upper * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Gastritis * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Dental Caries  1  0/12 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
General disorders       
Fatigue * 1  2/12 (16.67%)  0/3 (0.00%)  0/6 (0.00%) 
Influenza Like Illness * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Infections and infestations       
Nasopharyngitis  1  3/12 (25.00%)  0/3 (0.00%)  2/6 (33.33%) 
Rhinitis * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Bacteriuria * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Bronchitis  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Prostate Infection  1  0/7 (0.00%)  0/2 (0.00%)  1/3 (33.33%) 
Urinary Tract Infection  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Pharyngitis  1  0/12 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Bite * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Foot Fracture  1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Ligament Injury  1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Wound * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Renal Injury  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Muscle Contracture * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Osteoarthritis * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Tendonitis  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Nervous system disorders       
Dizziness * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Headache * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Neuropathy Peripheral * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Syncope * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Myelitis  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Restless Legs Syndrome  1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Psychiatric disorders       
Anxiety * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Insomnia * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Reproductive system and breast disorders       
Epididymitis  1  1/7 (14.29%)  0/2 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pharyngolaryngeal Pain * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Rhinitis Allergic * 1  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders       
Dermatitis Allergic * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Vascular disorders       
Orthostatic Hypotension * 1  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
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
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00661479     History of Changes
Other Study ID Numbers: 190342-028D
First Submitted: October 29, 2007
First Posted: April 18, 2008
Results First Submitted: March 13, 2013
Results First Posted: April 24, 2013
Last Update Posted: April 24, 2013