Trial · NCT00511875
Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
NCT00511875, Phase 2, Completed, Thomas Gardner; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy. Trials, record NCT00511875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00511875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
- NCT number
- NCT00511875
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Thomas Gardner
- Conditions
- Diabetic Retinopathy
- Interventions
- doxycycline monohydrate, placebo
- First posted
- 2007-08-06
- Last updated
- 2018-11-02
- Other registries' IDs
- eudract:2007-005601-22
- Results first posted
- 2018-11-02
- Limitations and caveats
- This is a proof of concept study.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Dark Adaptation, Rod Intercept | Baseline and 24 months | Change in dark adaptation is measured as dark adaptation time at baseline measured in minutes minus dark adaptation time measured at 24 months |
| Primary | Change in Photopic Visual Field | Baseline and 24 months | Change in photopic visual fields between baseline and 24 months |
| Primary | Change in Frequency Doubling Perimetry (FDP) | 24 months | Change in Frequency Doubling Perimetry (FDP) from baseline, shown as mean and foveal (center of retina) scores |
| Primary | Change in Early Treatment Diabetic Retinopathy Study (ETDRS) | Baseline and 24 months | Change in ETDRS visual acuity letter score from baseline. ETDRS is measured on a scale of 0 to 70 where 0 means inability to see anything on the chart and 70 is normal (20/20) acuity. |
| Secondary | Change in Central Subfield Thickness | Baseline and 24 months | Change in central subfield thickness from baseline |
| Secondary | Change in Macular Volume | 24 months | Change in macular volume from baseline |
| Secondary | Change in Central Retinal Artery Equivalent (CRAE) Diameter | 24 months | Change in Central Retinal Artery Equivalent (CRAE) diameter from baseline |
| Secondary | Change in Central Retinal Vein Equivalent (CRVE) Diameter | 24 months | Change in Central Retinal Vein Equivalent (CRVE) diameter from baseline |
| Secondary | Change in Arteriovenous Ratio Diameter | 24 months | Change in arteriovenous ratio diameter from baseline |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Dark Adaptation, Rod Intercept | Baseline and 24 months | Of 10 participants who completed doxycycline treatment, usable endpoint data is only available for 8. | minutes | MEAN |
| PRIMARY | Change in Photopic Visual Field | Baseline and 24 months | dB | MEAN | |
| PRIMARY | Change in Frequency Doubling Perimetry (FDP) | 24 months | dB | MEAN | |
| PRIMARY | Change in Early Treatment Diabetic Retinopathy Study (ETDRS) | Baseline and 24 months | score on a scale | MEAN | |
| SECONDARY | Change in Central Subfield Thickness | Baseline and 24 months | μm | MEAN | |
| SECONDARY | Change in Macular Volume | 24 months | mm^3 | MEAN | |
| SECONDARY | Change in Central Retinal Artery Equivalent (CRAE) Diameter | 24 months | μm | MEAN | |
| SECONDARY | Change in Central Retinal Vein Equivalent (CRVE) Diameter | 24 months | μm | MEAN | |
| SECONDARY | Change in Arteriovenous Ratio Diameter | 24 months | ratio | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Dark Adaptation, Rod Intercept | Placebo | 0.3 | Standard Deviation 3.3 | minutes | |
| Change in Dark Adaptation, Rod Intercept | Doxycycline Monohydrate | -0.3 | Standard Deviation 3.2 | minutes | |
| Change in Photopic Visual Field | Placebo | Foveal Sensitivity | -0.8 | Standard Deviation 12.2 | dB |
| Change in Photopic Visual Field | Doxycycline Monohydrate | Foveal Sensitivity | -0.8 | Standard Deviation 1.3 | dB |
| Change in Photopic Visual Field | Placebo | Mean Sensitivity | -0.74 | Standard Deviation 1.90 | dB |
| Change in Photopic Visual Field | Doxycycline Monohydrate | Mean Sensitivity | -1.0 | Standard Deviation 2.4 | dB |
| Change in Frequency Doubling Perimetry (FDP) | Placebo | Foveal Sensitivity | -1.9 | Standard Deviation 3.8 | dB |
| Change in Frequency Doubling Perimetry (FDP) | Doxycycline Monohydrate | Foveal Sensitivity | 1.8 | Standard Deviation 3.6 | dB |
| Change in Frequency Doubling Perimetry (FDP) | Placebo | Mean FDP sensitivity | -0.7 | Standard Deviation 3.9 | dB |
| Change in Frequency Doubling Perimetry (FDP) | Doxycycline Monohydrate | Mean FDP sensitivity | 0.7 | Standard Deviation 2.7 | dB |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxycycline Monohydrate | 15 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Doxycycline Monohydrate | 10 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Doxycycline Monohydrate | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events190
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 | abscess molar tooth (root canal) | Musculoskeletal and connective tissue disorders | Placebo | 1 | 15 | |
| other | abscess molar tooth (root canal) | Musculoskeletal and connective tissue disorders | Doxycycline Monohydrate | 0 | 15 | |
| other | allergic reaction - reason unknown | Immune system disorders | Placebo | 1 | 15 | |
| other | allergic reaction - reason unknown | Immune system disorders | Doxycycline Monohydrate | 0 | 15 | |
| other | allergies (seasonal) | Immune system disorders | Placebo | 1 | 15 | |
| other | allergies (seasonal) | Immune system disorders | Doxycycline Monohydrate | 0 | 15 | |
| other | ankle sprain (right) | Musculoskeletal and connective tissue disorders | Placebo | 1 | 15 | |
| other | ankle sprain (right) | Musculoskeletal and connective tissue disorders | Doxycycline Monohydrate | 0 | 15 | |
| other | anxiety (mild) | Psychiatric disorders | Placebo | 1 | 15 | |
| other | anxiety (mild) | Psychiatric disorders | Doxycycline Monohydrate | 1 | 15 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Doxycycline Monohydrate | ||
| Total, other adverse events | Placebo | 14 | 15 |
| Total, other adverse events | Doxycycline Monohydrate | 15 | 15 |
| Total, serious adverse events | Placebo | 3 | 15 |
| Total, serious adverse events | Doxycycline Monohydrate | 3 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24604308 | DERIVED |
Source PubMed
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 |
|---|
| Doxycycline Monohydrate vs Placebo: 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/NCT00511875
GET https://conductscience.org/api/trials/v1/NCT00511875/results?page=2