Trial · NCT00935883
Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
NCT00935883, Phase 2, Completed, Philip J. Rosenfeld, MD, PhD; results first posted 2015-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD). Trials, record NCT00935883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00935883
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
- NCT number
- NCT00935883
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Philip J. Rosenfeld, MD, PhD
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Eculizumab, Saline
- First posted
- 2009-07-09
- Last updated
- 2017-05-30
- Results first posted
- 2015-01-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Growth of Geographic Atrophy | 6 months | |
| Primary | Decrease in Drusen Volume | 6 Months | |
| Secondary | Change in Visual Acuity for Drusen Group | Baseline/ 6 Months | Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart. |
| Secondary | Change in Visual Acuity for Geographic Atrophy Group | Baseline/ 6 Months | Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Growth of Geographic Atrophy | 6 months | Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab | millimeters | MEAN |
| SECONDARY | Change in Visual Acuity for Drusen Group | Baseline/ 6 Months | Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab | letters | MEAN |
| PRIMARY | Decrease in Drusen Volume | 6 Months | Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab | mm^3 | MEAN |
| SECONDARY | Change in Visual Acuity for Geographic Atrophy Group | Baseline/ 6 Months | Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab | letters | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Growth of Geographic Atrophy | Saline | 0.18 | Standard Deviation 0.15 | millimeters | |
| Growth of Geographic Atrophy | Eculizumab | 0.19 | Standard Deviation 0.12 | millimeters | |
| Change in Visual Acuity for Drusen Group | Saline | 4.0 | Standard Deviation 7.0 | letters | |
| Change in Visual Acuity for Drusen Group | Eculizumab | 2.4 | Standard Deviation 3.9 | letters | |
| Decrease in Drusen Volume | Saline | 0.12 | Standard Deviation 0.08 | mm^3 | |
| Decrease in Drusen Volume | Eculizumab | 0.15 | Standard Deviation 0.17 | mm^3 | |
| Change in Visual Acuity for Geographic Atrophy Group | Saline | -2.6 | Standard Deviation 7.2 | letters | |
| Change in Visual Acuity for Geographic Atrophy Group | Eculizumab | 2.5 | Standard Deviation 4.1 | letters |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Saline | 20 | |
| Treatment Period | STARTED | Eculizumab | 40 | |
| Treatment Period | COMPLETED | Saline | 19 | |
| Treatment Period | COMPLETED | Eculizumab | 38 | |
| Treatment Period | NOT COMPLETED | Saline | 1 | |
| Treatment Period | NOT COMPLETED | Eculizumab | 2 | |
| Follow-Up Period | STARTED | Saline | 19 | |
| Follow-Up Period | STARTED | Eculizumab | 38 | |
| Follow-Up Period | COMPLETED | Saline | 19 | |
| Follow-Up Period | COMPLETED | Eculizumab | 38 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2
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 |
|---|---|---|---|---|---|---|
| other | chest pains | Cardiac disorders | Saline | 1 | 20 | 1 |
| other | chest pains | Cardiac disorders | Eculizumab | 0 | 40 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saline | ||
| Total, all-cause mortality | Eculizumab | ||
| Total, other adverse events | Saline | 1 | 20 |
| Total, other adverse events | Eculizumab | 0 | 40 |
| Total, serious adverse events | Saline | 0 | 20 |
| Total, serious adverse events | Eculizumab | 0 | 40 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Saline vs Eculizumab: serious adverse events |
Source Trial comparisons
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/NCT00935883
GET https://conductscience.org/api/trials/v1/NCT00935883/registered