Diabetic RetinopathyDRAGONSNCT05333055
Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Greater Houston Retina Research at 3 sites in United States.
Trial summary
The DRAGONS study is a non-interventional, prospective study that will 1. characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema, Other Retinal Disorders
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Feb 2022to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retina Consultants of Texas patient population
Who may be able to join
- 1. Subjects with at least one of the following retinal conditions in at least one eye:
- Treatment naive diabetic retinopathy (group 1 only);
- Diabetic retinopathy with DME that is incompletely responsive to anti-VEGF therapy at principal investigators discretion with retinal thickening documented on OCT (group 2 only);
- Various retinal disease including but not limited to diabetic retinopathy without DME which has previously been treated, DME which has responded to anti-VEGF therapy, neovascular age-related macular degeneration, branch or central retinal vein occlusions, epiretinal membrane, or macular hole (group 3 only)
Who cannot join
- Prior intraocular or subtenon steroid injection in the study eye within the prior 1 year of signing informed consent;
- Prior focal or grid laser photocoagulation in the study eye if within 90 days of signing informed consent;
- Prior panretinal photocoagulation in the study eye if within 90 days of signing informed consent;
- Intraocular or refractive surgery in the study eye within 90 days of signing informed consent;
- Systemic anti-VEGF treatment within 90 days of signing informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Retina Consultants of Texas
Bellaire, Texas, 77401
Retina Consultants of Texas
Katy, Texas, 77494
Retina Consultants of Texas
The Woodlands, Texas, 77384
About this study
The DRAGONS study is a non-interventional, prospective study that will
- characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other retinal pathologies, and
- correlate a broad array of aqueous humor disease state biomarkers with DR severity, DME anti-vascular endothelial growth factor (VEGF) responsiveness, and other retinal pathologies.
Read the detailed description
The DRAGONS study is a non-interventional study investigating aqueous humor biomarker levels in patients with various stages of DR, DME and other retinal pathologies.
Subjects will be included in the study if at least one eye meets any of the following criteria:
Group 1 - eyes with treatment naive DR with or without DME Group 2 - eyes with DME that are incompletely responsive to anti-VEGF therapy Group 3 - eyes with various retinal conditions including eyes with DR and DME that are anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole
The study will consist of a single visit and a retrospective chart review. The study visit will consist of:
- Screening for eligibility;
- Aqueous humor collection;
- Blood collection;
- Optical coherence tomography;
- Optical coherence tomography angiography;
- Fundus photography; and
- Fluorescein angiography.
Approximately 50 microliters (or more, up to 150 microliters) of aqueous fluid will be collected according to standard clinical procedures. Plasma and serum will be collected according to standard clinical procedures, with citrated plasma being specifically collected in a plastic tube.
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Eyes with treatment naive DR with or without DME | |
| Group 2 | Eyes with DME that are incompletely responsive to anti-VEGF therapy | |
| Group 3 | Eyes with various retinal conditions including eyes with DR and DME that is anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous Humor Levels of Disease State Biomarkers
Aqueous humor levels of cytokines, KKS metabolites, and cell adhesion molecules of subjects with various stages of diabetic retinopathy and diabetic macular edema as well as other retinal pathologies.
Measured: Baseline
Secondary outcomes (1)
Correlation of Biomarker Levels
Correlation of aqueous humor disease state biomarkers with diabetic retinopathy severity, diabetic macular edema anti-VEGF responsiveness, and other retinal pathologies.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start10 Feb 2022
- Primary completion15 May 2024
- Study completion15 May 2024
Why it stopped: Dissolution of the ophthalmology department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greater Houston Retina Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles C. Wykoff, MD, PhD, Principal investigator, Greater Houston Retina Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333055
- Sponsor's protocol ID
- DRAGONS
- Acronym
- DRAGONS
- Status last verified
- Sep 2024
- First submitted
- 11 Apr 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kempen JH, O'Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, Taylor HR, Hamman RF; Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):552-63. doi: 10.1001/archopht.122.4.552.
PubMed 15078674Leasher JL, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, Naidoo K, Pesudovs K, Price H, White RA, Wong TY, Resnikoff S, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global Estimates on the Number of People Blind or Visually Impaired by Diabetic Retinopathy: A Meta-analysis From 1990 to 2010. Diabetes Care. 2016 Sep;39(9):1643-9. doi: 10.2337/dc15-2171.
PubMed 27555623Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
PubMed 25104599Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.
PubMed 7526212Mesquida M, Drawnel F, Fauser S. The role of inflammation in diabetic eye disease. Semin Immunopathol. 2019 Jul;41(4):427-445. doi: 10.1007/s00281-019-00750-7. Epub 2019 Jun 7.
PubMed 31175392Mesquita J, Castro-de-Sousa JP, Vaz-Pereira S, Neves A, Passarinha LA, Tomaz CT. Evaluation of the growth factors VEGF-a and VEGF-B in the vitreous and serum of patients with macular and retinal vascular diseases. Growth Factors. 2018 Apr;36(1-2):48-57. doi: 10.1080/08977194.2018.1477140. Epub 2018 Jul 3.
PubMed 29969324Amadio M, Govoni S, Pascale A. Targeting VEGF in eye neovascularization: What's new?: A comprehensive review on current therapies and oligonucleotide-based interventions under development. Pharmacol Res. 2016 Jan;103:253-69. doi: 10.1016/j.phrs.2015.11.027. Epub 2015 Dec 8.
PubMed 26678602Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003 Jan;22(1):1-29. doi: 10.1016/s1350-9462(02)00043-5.
PubMed 12597922Zhang X, Bao S, Lai D, Rapkins RW, Gillies MC. Intravitreal triamcinolone acetonide inhibits breakdown of the blood-retinal barrier through differential regulation of VEGF-A and its receptors in early diabetic rat retinas. Diabetes. 2008 Apr;57(4):1026-33. doi: 10.2337/db07-0982. Epub 2008 Jan 3.
PubMed 18174522Hofman P, Blaauwgeers HG, Tolentino MJ, Adamis AP, Nunes Cardozo BJ, Vrensen GF, Schlingemann RO. VEGF-A induced hyperpermeability of blood-retinal barrier endothelium in vivo is predominantly associated with pinocytotic vesicular transport and not with formation of fenestrations. Vascular endothelial growth factor-A. Curr Eye Res. 2000 Aug;21(2):637-45.
PubMed 11148600Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
PubMed 2062512Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600.
PubMed 7196564Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.
PubMed 20427088Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, Gibson A, Sy J, Rundle AC, Hopkins JJ, Rubio RG, Ehrlich JS; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801. doi: 10.1016/j.ophtha.2011.12.039. Epub 2012 Feb 11.
PubMed 22330964Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.
PubMed 25012934
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Biomarker Levels in Diabetic Retinopathy and Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05333055
- Acronym / sponsor ID
- DRAGONS / DRAGONS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Dissolution of the ophthalmology department
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Greater Houston Retina ResearchUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DRAGONS study is a non-interventional, prospective study that will
- characterize disease state biomarker (including cytokines, KKS metabolites, and cell adhesion molecules) levels from aqueous humor of subjects with various stages of diabetic retinopathy (DR) and diabetic macular edema (DME) as well as other retinal pathologies, and
- correlate a broad array of aqueous humor disease state biomarkers with DR severity, DME anti-vascular endothelial growth factor (VEGF) responsiveness, and other retinal pathologies.
Detailed description
The DRAGONS study is a non-interventional study investigating aqueous humor biomarker levels in patients with various stages of DR, DME and other retinal pathologies.
Subjects will be included in the study if at least one eye meets any of the following criteria:
Group 1 - eyes with treatment naive DR with or without DME Group 2 - eyes with DME that are incompletely responsive to anti-VEGF therapy Group 3 - eyes with various retinal conditions including eyes with DR and DME that are anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole
The study will consist of a single visit and a retrospective chart review. The study visit will consist of:
- Screening for eligibility;
- Aqueous humor collection;
- Blood collection;
- Optical coherence tomography;
- Optical coherence tomography angiography;
- Fundus photography; and
- Fluorescein angiography.
Approximately 50 microliters (or more, up to 150 microliters) of aqueous fluid will be collected according to standard clinical procedures. Plasma and serum will be collected according to standard clinical procedures, with citrated plasma being specifically collected in a plastic tube.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Eyes with treatment naive DR with or without DME |
| Group 2 | – | –Eyes with DME that are incompletely responsive to anti-VEGF therapy |
| Group 3 | – | –Eyes with various retinal conditions including eyes with DR and DME that is anti-VEGF responsive as well as non-exudative retinal pathologies such as epiretinal membrane and macular hole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retina Consultants of Texas patient population
Key inclusion criteria (4 listed)
- Treatment naive diabetic retinopathy (group 1 only);
- Diabetic retinopathy with DME that is incompletely responsive to anti-VEGF therapy at principal investigators discretion with retinal thickening documented on OCT (group 2 only);
- Various retinal disease including but not limited to diabetic retinopathy without DME which has previously been treated, DME which has responded to anti-VEGF therapy, neovascular age-related macular degeneration, branch or central retinal vein occlusions, epiretinal membrane, or macular hole (group 3 only)
Key exclusion criteria (5 listed)
- Prior intraocular or subtenon steroid injection in the study eye within the prior 1 year of signing informed consent;
- Prior focal or grid laser photocoagulation in the study eye if within 90 days of signing informed consent;
- Prior panretinal photocoagulation in the study eye if within 90 days of signing informed consent;
- Intraocular or refractive surgery in the study eye within 90 days of signing informed consent;
- Systemic anti-VEGF treatment within 90 days of signing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aqueous Humor Levels of Disease State Biomarkers
Time frame: Baseline
Aqueous humor levels of cytokines, KKS metabolites, and cell adhesion molecules of subjects with various stages of diabetic retinopathy and diabetic macular edema as well as other retinal pathologies.
1 secondary outcome
Correlation of Biomarker Levels
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Dissolution of the ophthalmology department). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 15078674Kempen JH, O'Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, Taylor HR, Hamman RF; Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):552-63. doi: 10.1001/archopht.122.4.552.
- Background: PubMed 27555623Leasher JL, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, Naidoo K, Pesudovs K, Price H, White RA, Wong TY, Resnikoff S, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global Estimates on the Number of People Blind or Visually Impaired by Diabetic Retinopathy: A Meta-analysis From 1990 to 2010. Diabetes Care. 2016 Sep;39(9):1643-9. doi: 10.2337/dc15-2171.
- Background: PubMed 25104599Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
- Background: PubMed 7526212Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.
- Background: PubMed 31175392Mesquida M, Drawnel F, Fauser S. The role of inflammation in diabetic eye disease. Semin Immunopathol. 2019 Jul;41(4):427-445. doi: 10.1007/s00281-019-00750-7. Epub 2019 Jun 7.
- Background: PubMed 29969324Mesquita J, Castro-de-Sousa JP, Vaz-Pereira S, Neves A, Passarinha LA, Tomaz CT. Evaluation of the growth factors VEGF-a and VEGF-B in the vitreous and serum of patients with macular and retinal vascular diseases. Growth Factors. 2018 Apr;36(1-2):48-57. doi: 10.1080/08977194.2018.1477140. Epub 2018 Jul 3.
- Background: PubMed 26678602Amadio M, Govoni S, Pascale A. Targeting VEGF in eye neovascularization: What's new?: A comprehensive review on current therapies and oligonucleotide-based interventions under development. Pharmacol Res. 2016 Jan;103:253-69. doi: 10.1016/j.phrs.2015.11.027. Epub 2015 Dec 8.
- Background: PubMed 12597922Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003 Jan;22(1):1-29. doi: 10.1016/s1350-9462(02)00043-5.
- Background: PubMed 18174522Zhang X, Bao S, Lai D, Rapkins RW, Gillies MC. Intravitreal triamcinolone acetonide inhibits breakdown of the blood-retinal barrier through differential regulation of VEGF-A and its receptors in early diabetic rat retinas. Diabetes. 2008 Apr;57(4):1026-33. doi: 10.2337/db07-0982. Epub 2008 Jan 3.
- Background: PubMed 11148600Hofman P, Blaauwgeers HG, Tolentino MJ, Adamis AP, Nunes Cardozo BJ, Vrensen GF, Schlingemann RO. VEGF-A induced hyperpermeability of blood-retinal barrier endothelium in vivo is predominantly associated with pinocytotic vesicular transport and not with formation of fenestrations. Vascular endothelial growth factor-A. Curr Eye Res. 2000 Aug;21(2):637-45.
- Background: PubMed 2062512Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
- Background: PubMed 7196564Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600.
- 2016 Global Report on DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles C. Wykoff, MD, PhD principal investigator
Greater Houston Retina Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Greater Houston Retina Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Dissolution of the ophthalmology department). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aqueous Humor Levels of Disease State Biomarkers (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05333055, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.