Trial · NCT00931489
Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)
NCT00931489, Phase 2, Completed, Lawrence S. Morse, MD; results first posted 2017-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD). Trials, record NCT00931489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00931489
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)
- NCT number
- NCT00931489
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Lawrence S. Morse, MD
- Conditions
- Age Related Macular Degeneration
- Interventions
- ranibizumab (Lucentis(R))
- First posted
- 2009-07-02
- Last updated
- 2017-07-02
- Results first posted
- 2017-07-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | Change in Visual Acuity (VA) From Baseline to Month 6 | 6 months | 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. |
| Secondary | Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6 | 6 months | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | participants | NUMBER |
| SECONDARY | Change in Visual Acuity (VA) From Baseline to Month 6 | 6 months | 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). | letters gained | MEAN |
| SECONDARY | Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6 | 6 months | 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). | µm | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular (Wet) Age-related Macular Degeneration Patients Compared to Population Normals. | Neovascular Wet Age-related Macular Degeneration Patients | Baseline | 31 | 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. | Population Normals | Baseline | 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. | Neovascular Wet Age-related Macular Degeneration Patients | 6 Months | 36 | participants | |
| Change in Visual Acuity (VA) From Baseline to Month 6 | Neovascular Wet AMD Patients - Responders | 10.08 | Full Range -10 to 44 | letters gained | |
| Change in Visual Acuity (VA) From Baseline to Month 6 | Neovascular Wet AMD Patients - Acute Non-responders | 6.14 | Full Range 1 to 12 | letters gained | |
| Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6 | Neovascular Wet AMD Patients - Responders | -82 | Full Range -472 to 35 | µm | |
| Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6 | Neovascular Wet AMD Patients - Acute Non-responders | 22 | Full Range -72 to 171 | µm |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Wet AMD Patients Responders | 40 | |
| Overall Study | STARTED | Normal Population | 40 | |
| Overall Study | STARTED | Wet AMD Patients Acute Non-responders | 5 | |
| Overall Study | STARTED | Dry AMD Population | 39 | |
| Overall Study | STARTED | Wet AMD Patients Chronic Non-responderes | 7 | |
| Overall Study | COMPLETED | Wet AMD Patients Responders | 40 | |
| Overall Study | COMPLETED | Normal Population | 40 | |
| Overall Study | COMPLETED | Wet AMD Patients Acute Non-responders | 5 | |
| Overall Study | COMPLETED | Dry AMD Population | 39 | |
| Overall Study | COMPLETED | Wet AMD Patients Chronic Non-responderes | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Uveitis | Eye disorders | Wet AMD Patients Responders | 1 | 40 | 1 |
| serious | Uveitis | Eye disorders | Normal Population | 0 | 40 | 0 |
| serious | Uveitis | Eye disorders | Wet AMD Patients Acute Non-responders | 0 | 5 | 0 |
| serious | Uveitis | Eye disorders | Dry AMD Population | 0 | 40 | 0 |
| serious | Uveitis | Eye disorders | Wet AMD Patients Chronic Non-responderes | 0 | 7 | 0 |
Source ClinicalTrials.gov
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Wet AMD Patients Responders | ||
| Total, all-cause mortality | Normal Population | ||
| Total, all-cause mortality | Wet AMD Patients Acute Non-responders | ||
| Total, all-cause mortality | Dry AMD Population | ||
| Total, all-cause mortality | Wet AMD Patients Chronic Non-responderes | ||
| Total, other adverse events | Wet AMD Patients Responders | 0 | 40 |
| Total, other adverse events | Normal Population | 0 | 40 |
| Total, other adverse events | Wet AMD Patients Acute Non-responders | 0 | 5 |
| Total, other adverse events | Dry AMD Population | 0 | 40 |
| Total, other adverse events | Wet AMD Patients Chronic Non-responderes | 0 | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00931489
GET https://conductscience.org/api/trials/v1/NCT00931489/registered