Trial Outcomes & Findings for Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD) (NCT NCT00931489)
NCT ID: NCT00931489
Last Updated: 2017-07-02
Results Overview
Blood samples were collected from all study participants at baseline and Western Blot analysis was performed to identify the presence of anti-retinal and anti-RPE antibodies. Presented are the number of subjects in which the presence of anti-retinal and anti-RPE antibodies (yes/no) were recorded by a masked observer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
6 months
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Wet AMD Patients Responders
Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Normal Population
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
|
Wet AMD Patients Acute Non-responders
Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Dry AMD Population
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
|
Wet AMD Patients Chronic Non-responderes
Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
5
|
39
|
7
|
|
Overall Study
COMPLETED
|
40
|
40
|
5
|
39
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Wet AMD Patients Responders
n=40 Participants
Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Normal Population
n=40 Participants
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
|
Wet AMD Patients Acute Non-responders
n=5 Participants
Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Dry AMD Population
n=39 Participants
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
|
Wet AMD Patients Chronic Non-responderes
n=7 Participants
Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
80.35 Years
STANDARD_DEVIATION 9.24 • n=93 Participants
|
67.82 Years
STANDARD_DEVIATION 7.39 • n=4 Participants
|
78.20 Years
STANDARD_DEVIATION 8.41 • n=27 Participants
|
77.08 Years
STANDARD_DEVIATION 9.50 • n=483 Participants
|
82.86 Years
STANDARD_DEVIATION 8.41 • n=36 Participants
|
75.60 Years
STANDARD_DEVIATION 10.15 • n=10 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
75 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
56 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The "wet" AMD patients' 6 month values in production of RPE or anti-retinal antibody formation are being compared to the Normal Population baseline values.
Blood samples were collected from all study participants at baseline and Western Blot analysis was performed to identify the presence of anti-retinal and anti-RPE antibodies. Presented are the number of subjects in which the presence of anti-retinal and anti-RPE antibodies (yes/no) were recorded by a masked observer.
Outcome measures
| Measure |
Neovascular "Wet" Age-related Macular Degeneration Patients
n=45 Participants
Subjects with active neovascular ("wet") AMD. This includes the subjects that responded to treatment (Ranibizumab 0.5mg intravitreal injections at four week intervals) Group 1, and chronic "non-responders" - those subjects who received four or more anti-VEGF intravitreal injections with persistent fluid on OCT, Group 3.
At baseline, 40 subjects were enrolled into Group 1 Following 4 months of treatment, 3 subjects were moved to Group 3.
|
Population Normals
n=40 Participants
Normals are subjects that do not have Age-related Macular Degeneration. Group 2
|
|---|---|---|
|
Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular ("Wet") Age-related Macular Degeneration Patients Compared to Population Normals.
Baseline
|
31 participants
|
26 participants
|
|
Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular ("Wet") Age-related Macular Degeneration Patients Compared to Population Normals.
6 Months
|
36 participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of "non-responder" following 4 months of treatment).
Subjects visual acuity (VA) was tested using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letters correctly read on ETDRS chart was recorded at baseline and 6 months. Mean change was measured.
Outcome measures
| Measure |
Neovascular "Wet" Age-related Macular Degeneration Patients
n=37 Participants
Subjects with active neovascular ("wet") AMD. This includes the subjects that responded to treatment (Ranibizumab 0.5mg intravitreal injections at four week intervals) Group 1, and chronic "non-responders" - those subjects who received four or more anti-VEGF intravitreal injections with persistent fluid on OCT, Group 3.
At baseline, 40 subjects were enrolled into Group 1 Following 4 months of treatment, 3 subjects were moved to Group 3.
|
Population Normals
n=8 Participants
Normals are subjects that do not have Age-related Macular Degeneration. Group 2
|
|---|---|---|
|
Change in Visual Acuity (VA) From Baseline to Month 6
|
10.08 letters gained
Interval -10.0 to 44.0
|
6.14 letters gained
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of "non-responder" following 4 months of treatment).
Ocular Coherence Tomography (OCT) was used to measure retinal central foveal thickness. The mean change from baseline to 6 months was determined and recorded in micrometers (µm).
Outcome measures
| Measure |
Neovascular "Wet" Age-related Macular Degeneration Patients
n=37 Participants
Subjects with active neovascular ("wet") AMD. This includes the subjects that responded to treatment (Ranibizumab 0.5mg intravitreal injections at four week intervals) Group 1, and chronic "non-responders" - those subjects who received four or more anti-VEGF intravitreal injections with persistent fluid on OCT, Group 3.
At baseline, 40 subjects were enrolled into Group 1 Following 4 months of treatment, 3 subjects were moved to Group 3.
|
Population Normals
n=8 Participants
Normals are subjects that do not have Age-related Macular Degeneration. Group 2
|
|---|---|---|
|
Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6
|
-82 µm
Interval -472.0 to 35.0
|
22 µm
Interval -72.0 to 171.0
|
Adverse Events
Wet AMD Patients Responders
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Population
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wet AMD Patients Acute Non-responders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dry AMD Population
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wet AMD Patients Chronic Non-responderes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Wet AMD Patients Responders
n=40 participants at risk
Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Normal Population
n=40 participants at risk
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
|
Wet AMD Patients Acute Non-responders
n=5 participants at risk
Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
Dry AMD Population
n=40 participants at risk
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
|
Wet AMD Patients Chronic Non-responderes
n=7 participants at risk
Participants in this Group will have not responded to 4 or more prior injections of anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn
ranibizumab (Lucentis(R)): 0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
|
|---|---|---|---|---|---|
|
Eye disorders
Uveitis
|
2.5%
1/40 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/40 • 6 months
|
0.00%
0/7 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Lawrence S. Morse, MD, PhD
University of California Davis, Department of Ophthalmology & Vision Science
Phone: 916 734 6074
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place