Trial · NCT00917553

Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy

NCT00917553, Phase 2, Completed, Thomas Gardner; results first posted 2018-11-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy. Trials, record NCT00917553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00917553

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy
NCT number: NCT00917553
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Thomas Gardner
Conditions: Diabetic Retinopathy
Interventions: doxycycline monohydrate, Placebo
First posted: 2009-06-10
Last updated: 2018-11-30
Results first posted: 2018-11-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group	Baseline and 24 months
Secondary	Change Thickness Thickness	Baseline and 24 months	Anatomic outcomes were assessed through optical coherence. Positive numbers indicate increases in thickness.
Secondary	Change in Macular Volume	Baseline and 24 months
Secondary	Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level	Baseline to 24 months	Participants are shown categorically by whether they reached PDR, or whether their diabetic retinopathy levels changed by one grade or more, as analyzed by fundus photography.
Secondary	Number of Participants Who Developed Vitreous or Preretinal Hemorrhage	24 months	Any participants who developed vitreous or preretinal hemorrhage were counted. Had there been any preretinal hemorrhages (a subcategory of vitreous hemorrhage) these would have been shown as a separate row.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group	Baseline and 24 months	Two participants in the placebo group and one in the doxycycline group were unavailable for 24 month results.	dB	MEAN
SECONDARY	Change Thickness Thickness	Baseline and 24 months		µm	MEAN
SECONDARY	Change in Macular Volume	Baseline and 24 months		mm^3	MEAN
SECONDARY	Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level	Baseline to 24 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Developed Vitreous or Preretinal Hemorrhage	24 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group	Placebo		2.80	Standard Deviation 3.80	dB
The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group	Doxycycline Monohydrate		0.13	Standard Deviation 4.45	dB
Change Thickness Thickness	Placebo	Central subfield thickness	17.5	Standard Deviation 27.3	µm
Change Thickness Thickness	Doxycycline Monohydrate	Central subfield thickness	21.3	Standard Deviation 72.5	µm
Change Thickness Thickness	Placebo	Center point thickness	25.6	Standard Deviation 41.7	µm
Change Thickness Thickness	Doxycycline Monohydrate	Center point thickness	26.1	Standard Deviation 81.1	µm
Change in Macular Volume	Placebo		0.06	Standard Deviation 0.34	mm^3
Change in Macular Volume	Doxycycline Monohydrate		0.23	Standard Deviation 0.67	mm^3
Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level	Placebo	Progressed to PDR	0		Participants
Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level	Doxycycline Monohydrate	Progressed to PDR	1		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	17
Overall Study	STARTED	Doxycycline Monohydrate	16
Overall Study	COMPLETED	Placebo	15
Overall Study	COMPLETED	Doxycycline Monohydrate	15
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Doxycycline Monohydrate	1

Source ClinicalTrials.gov

Adverse events160

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
other	glaucoma	Eye disorders	Placebo	0	17
other	glaucoma	Eye disorders	Doxycycline Monohydrate	1	16
other	4 broken toes left foot	Musculoskeletal and connective tissue disorders	Placebo	0	17
other	4 broken toes left foot	Musculoskeletal and connective tissue disorders	Doxycycline Monohydrate	1	16
other	acid reflux	Gastrointestinal disorders	Placebo	2	17
other	acid reflux	Gastrointestinal disorders	Doxycycline Monohydrate	0	16
other	arm weakness and numbness	Musculoskeletal and connective tissue disorders	Placebo	1	17
other	arm weakness and numbness	Musculoskeletal and connective tissue disorders	Doxycycline Monohydrate	0	16
other	arthritis	Musculoskeletal and connective tissue disorders	Placebo	0	17
other	arthritis	Musculoskeletal and connective tissue disorders	Doxycycline Monohydrate	2	16

1 to 10 of 160Source ClinicalTrials.gov

See all 160 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	17
Total, all-cause mortality	Doxycycline Monohydrate	0	16
Total, other adverse events	Placebo	16	17
Total, other adverse events	Doxycycline Monohydrate	14	16
Total, serious adverse events	Placebo	4	17
Total, serious adverse events	Doxycycline Monohydrate	8	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24969516	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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Doxycycline Monohydrate vs Placebo: Number of Participants Who Developed Vitreous or Preretinal Hemorrhage	Trial comparisons
Doxycycline Monohydrate vs Placebo: deaths from any cause	Trial comparisons
Doxycycline Monohydrate vs Placebo: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00917553

GET https://conductscience.org/api/trials/v1/NCT00917553/events?page=2

API reference For AI assistants