Diabetic Macular EdemaNCT05416099
Comparing Conventional Grid Laser Photocoagulation and Subthreshold Micropulse Laser in Diabetic Macular Edema Using OCT Angiography
An observational study of Diabetic Macular Edema, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The prevalence of diabetes mellitus has increased significantly in Hong Kong for the past decade [1]. Diabetic macular edema is one of the most common causes of vision loss in patients suffering from diabetes mellitus [3]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- laser
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Dec 2022
- 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: Patients with diabetic macular edema and central retinal thickness >400micrometers who have not received any treatments within 6 months
Who may be able to join
- Patients with best-corrected visual acuity better than 20/200 (checked with refraction test)
- Patients with clinically significant diabetic macular edema (DME) who have not received any treatment within 6 months
- Patients with central retinal thickness equal / above to around 400 um
- Patients who are able to have regular visits after laser treatment for at least 6 months
Who cannot join
- Children under the age of 18
- Patients with proliferative diabetic retinopathy
- Patients with co-existing retinal or macular disease, including epiretinal membrane and vitreomacular traction
- Patients with previous history of laser photocoagulation, anti-VEGF injection, intravitreal steroid injection, vitreoretinal or cataract surgery within a period of 6 months
- Patients with history of uveitis
- Patients who are unfit or for capturing of OCT-A images
Show all 9Show fewer
- Patients with significant media opacity that may interfere with fundal examination and the acquisition of high quality OCT-A images
- Patients who are unable to give informed consent to enter the study
- uncooperative
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
chinese university of Hong kong
Hong Kong
Gabriel KH Li, M.B. Ch.B
About this study
The prevalence of diabetes mellitus has increased significantly in Hong Kong for the past decade [1]. Diabetic macular edema is one of the most common causes of vision loss in patients suffering from diabetes mellitus [3]. Before the introduction of anti-vascular endothelial growth factor agents, laser photocoagulation has been the mainstay treatment for patients with diabetic macular edema. There are two types of laser treatment modalities, namely focal laser, which can be applied either in a grid pattern over a region of macular edema or to selected microaneurysms, and subthreshold micropulse laser. Only one meta-analysis published in 2016 [16] had previously demonstrated superiority of micropulse laser over focal laser, while other studies showed no clinically significant differences between the two lasers. Nevertheless, micropulse laser had been proven to cause no structural changes to the retina and choroid, as opposed to focal laser.
Optical coherence tomography angiography (OCT-A) is a new, non-invasive imaging technique that allows a clear, depth-resolved visualization of the retinal and choroidal microvasculature in the macular region [22]. A recent case series study [17] has demonstrated early changes of retinal vasculature on OCT-A images after micropulse laser for diabetic macular edema. Another cross-sectional study [18] showed choriocapillaries alterations in some of the patients after receiving focal laser. We would like to compare the changes of different OCT-A parameters for patients receiving either type of laser, and hence evaluating their efficacy.
We propose to take OCT-A images for patients before laser, 1-, 3- and 6-months post-laser based on the results of a recent case series [17]. We will analyse the OCT-A images with MATLAB software and compare the changes in different parameters between both lasers.
Read the detailed description
Laser photocoagulation was previously a mainstay treatment for DME before the introduction of anti-vascular endothelial growth factor (anti-VEGF) agents injection. Vascular endothelial growth factor (VEGF) is an important mediator of blood-retinal barrier breakdown, which leads to fluid leakage and the development of macular edema [5]. Observing that intraocular VEGF levels are increased in DME, using VEGF inhibitors (anti-VEGF) was found to be beneficial in reversing vision loss from macular edema [6]. In recent years, many large-scale studies [7], [8], [9], [10] had proven that anti-VEGF injections resulted in superior improvements in visual acuity and central subfield thickness than laser photocoagulation in treating DME. This has led to the decline of conventional focal laser as a first-line therapy.
However, in our clinical setting, laser photocoagulation may still be preferred in selected clinical scenarios in treating DME. In Hong Kong, anti-VEGF agents were self-financed items for patients in the public sector of our healthcare system. These medications could be a huge financial burden to patients with low financial support, and therefore they might prefer laser therapy instead.
Furthermore, anti-VEGF intravitreal injections have been reported to have detectable levels in systemic circulation, which can lead to systemic complications. A retrospective study [11] of 1173 patients showed that bevacizumab has a risk of leading to systemic events including acute blood pressure elevation (0.59%), cerebrovascular accidents (0.5%), myocardial infarctions (0.4%), and iliac artery aneurysms (0.17%). Hence, patients with recent history of cardiovascular accidents or significant cardiovascular comorbidities and patients who could not tolerate intravitreal injections might also find laser therapy a better option in treating DME.
Therefore, it is still useful to compare the effectiveness of conventional focal/grid laser versus subthreshold micropulse in treating DME in our clinical context. Previous studies [12], [13], [14] had mainly demonstrated non-inferiority of subthreshold micropulse laser in terms of best-corrected visual acuity (BCVA), contrast sensitivity and central retinal thickness. Nonetheless, majority of the studies demonstrated that laser scars were much more frequently identified in conventional laser than micropulse laser-treated eyes.
Optical coherence tomography angiography (OCT-A) is a new, non-invasive imaging technique to visualize the retinal vasculature and choroidal vascular layers in the macular area. It employs motion contrast imaging to high-resolution volumetric blood flow information, generating angiographic images in seconds. The principle of OCT-A involves the comparison of decorrelation signal between sequential Optical Coherence Tomography (OCT) B-scans taken at precisely the same cross-section, therefore constructing a map of blood flow. Given that only erythrocyte movements in the blood vessels are represented and axial bulk motions are eliminated, determining a vascular decorrelation signal enables visualization of 3-dimensional retinal and choroidal vascular network without the administration of intravenous dye and thus reducing the risk of potential adverse events [17], [22].
The authors believe that OCT-A can be used as a new assessment tool in comparing the efficacy of conventional focal laser versus subthreshold micropulse laser in the treatment of DME. We hypothesize that subthreshold micropulse laser is superior to focal laser in treating patients with DME in terms of OCT-A parameters. We expect the reduction in the studied OCT-A parameters (i.e. FAZ area, area of cysts, number of microaneurysms, etc.) in patients receiving subthreshold micropulse laser will be greater than focal laser by 30%.
- Conditions
- Diabetic Macular Edema
- Being tested
- laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laserProcedure or surgery
grid vs micropulse laser
| Study group | Role | What they receive |
|---|---|---|
| Grid laser | grid laser is one of the more conventional treatments for diabetic macular edema Receives: Procedure: laser | |
| micropulse laser | micropulse laser is one of the more recent treatments for diabetic macular edema Receives: Procedure: laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity
Measured: 1 month, 3 month and 6 months
Secondary outcomes (1)
Change in OCTA parameters
Change in OCT measurement of FAZ area
Measured: 1 month, 3 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Li, Chinese University of Hong Kong
- Investigators
- Gabriel HK Li, M.B. Ch.B, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416099
- Sponsor's protocol ID
- gridvsmicropulseDMEOCTA
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Quan J, Li TK, Pang H, Choi CH, Siu SC, Tang SY, Wat NMS, Woo J, Johnston JM, Leung GM. Diabetes incidence and prevalence in Hong Kong, China during 2006-2014. Diabet Med. 2017 Jul;34(7):902-908. doi: 10.1111/dme.13284. Epub 2016 Nov 29.
PubMed 27859570Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
PubMed 2866759Bandello F, Battaglia Parodi M, Lanzetta P, Loewenstein A, Massin P, Menchini F, Veritti D. Diabetic Macular Edema. Dev Ophthalmol. 2017;58:102-138. doi: 10.1159/000455277. Epub 2017 Mar 28.
PubMed 28351052Wan KH, Chen LJ, Young AL. Screening and Referral of Diabetic Retinopathy: A Comparative Review of the Practice Guidelines. Asia Pac J Ophthalmol (Phila). 2013 Sep-Oct;2(5):310-6. doi: 10.1097/APO.0b013e31829df4a3.
PubMed 26107035Qaum T, Xu Q, Joussen AM, Clemens MW, Qin W, Miyamoto K, Hassessian H, Wiegand SJ, Rudge J, Yancopoulos GD, Adamis AP. VEGF-initiated blood-retinal barrier breakdown in early diabetes. Invest Ophthalmol Vis Sci. 2001 Sep;42(10):2408-13.
PubMed 11527957Funatsu H, Yamashita H, Noma H, Mimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2002 Jan;133(1):70-7. doi: 10.1016/s0002-9394(01)01269-7.
PubMed 11755841Nguyen QD, Shah SM, Heier JS, Do DV, Lim J, Boyer D, Abraham P, Campochiaro PA; READ-2 Study Group. Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in diabetes (READ-2) study. Ophthalmology. 2009 Nov;116(11):2175-81.e1. doi: 10.1016/j.ophtha.2009.04.023. Epub 2009 Aug 22.
PubMed 19700194Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):615-25. doi: 10.1016/j.ophtha.2011.01.031.
PubMed 21459215Ishibashi T, Li X, Koh A, Lai TY, Lee FL, Lee WK, Ma Z, Ohji M, Tan N, Cha SB, Shamsazar J, Yau CL; REVEAL Study Group. The REVEAL Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy in Asian Patients with Diabetic Macular Edema. Ophthalmology. 2015 Jul;122(7):1402-15. doi: 10.1016/j.ophtha.2015.02.006. Epub 2015 May 14.
PubMed 25983216Korobelnik 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 25012934Wu L, Martinez-Castellanos MA, Quiroz-Mercado H, Arevalo JF, Berrocal MH, Farah ME, Maia M, Roca JA, Rodriguez FJ; Pan American Collaborative Retina Group (PACORES). Twelve-month safety of intravitreal injections of bevacizumab (Avastin): results of the Pan-American Collaborative Retina Study Group (PACORES). Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):81-7. doi: 10.1007/s00417-007-0660-z. Epub 2007 Aug 3.
PubMed 17674014Figueira J, Khan J, Nunes S, Sivaprasad S, Rosa A, de Abreu JF, Cunha-Vaz JG, Chong NV. Prospective randomised controlled trial comparing sub-threshold micropulse diode laser photocoagulation and conventional green laser for clinically significant diabetic macular oedema. Br J Ophthalmol. 2009 Oct;93(10):1341-4. doi: 10.1136/bjo.2008.146712. Epub 2008 Dec 3.
PubMed 19054831Vujosevic S, Bottega E, Casciano M, Pilotto E, Convento E, Midena E. Microperimetry and fundus autofluorescence in diabetic macular edema: subthreshold micropulse diode laser versus modified early treatment diabetic retinopathy study laser photocoagulation. Retina. 2010 Jun;30(6):908-16. doi: 10.1097/IAE.0b013e3181c96986.
PubMed 20168272Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.
PubMed 21345996Venkatesh P, Ramanjulu R, Azad R, Vohra R, Garg S. Subthreshold micropulse diode laser and double frequency neodymium: YAG laser in treatment of diabetic macular edema: a prospective, randomized study using multifocal electroretinography. Photomed Laser Surg. 2011 Nov;29(11):727-33. doi: 10.1089/pho.2010.2830. Epub 2011 May 25.
PubMed 21612513
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Conventional Grid Laser Photocoagulation and Subthreshold Micropulse Laser in Diabetic Macular Edema Using OCT Angiography
- ClinicalTrials.gov ID
- NCT05416099
- Acronym / sponsor ID
- gridvsmicropulseDMEOCTA
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 13 Jun 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 prevalence of diabetes mellitus has increased significantly in Hong Kong for the past decade [1]. Diabetic macular edema is one of the most common causes of vision loss in patients suffering from diabetes mellitus [3]. Before the introduction of anti-vascular endothelial growth factor agents, laser photocoagulation has been the mainstay treatment for patients with diabetic macular edema. There are two types of laser treatment modalities, namely focal laser, which can be applied either in a grid pattern over a region of macular edema or to selected microaneurysms, and subthreshold micropulse laser. Only one meta-analysis published in 2016 [16] had previously demonstrated superiority of micropulse laser over focal laser, while other studies showed no clinically significant differences between the two lasers. Nevertheless, micropulse laser had been proven to cause no structural changes to the retina and choroid, as opposed to focal laser.
Optical coherence tomography angiography (OCT-A) is a new, non-invasive imaging technique that allows a clear, depth-resolved visualization of the retinal and choroidal microvasculature in the macular region [22]. A recent case series study [17] has demonstrated early changes of retinal vasculature on OCT-A images after micropulse laser for diabetic macular edema. Another cross-sectional study [18] showed choriocapillaries alterations in some of the patients after receiving focal laser. We would like to compare the changes of different OCT-A parameters for patients receiving either type of laser, and hence evaluating their efficacy.
We propose to take OCT-A images for patients before laser, 1-, 3- and 6-months post-laser based on the results of a recent case series [17]. We will analyse the OCT-A images with MATLAB software and compare the changes in different parameters between both lasers.
Detailed description
Laser photocoagulation was previously a mainstay treatment for DME before the introduction of anti-vascular endothelial growth factor (anti-VEGF) agents injection. Vascular endothelial growth factor (VEGF) is an important mediator of blood-retinal barrier breakdown, which leads to fluid leakage and the development of macular edema [5]. Observing that intraocular VEGF levels are increased in DME, using VEGF inhibitors (anti-VEGF) was found to be beneficial in reversing vision loss from macular edema [6]. In recent years, many large-scale studies [7], [8], [9], [10] had proven that anti-VEGF injections resulted in superior improvements in visual acuity and central subfield thickness than laser photocoagulation in treating DME. This has led to the decline of conventional focal laser as a first-line therapy.
However, in our clinical setting, laser photocoagulation may still be preferred in selected clinical scenarios in treating DME. In Hong Kong, anti-VEGF agents were self-financed items for patients in the public sector of our healthcare system. These medications could be a huge financial burden to patients with low financial support, and therefore they might prefer laser therapy instead.
Furthermore, anti-VEGF intravitreal injections have been reported to have detectable levels in systemic circulation, which can lead to systemic complications. A retrospective study [11] of 1173 patients showed that bevacizumab has a risk of leading to systemic events including acute blood pressure elevation (0.59%), cerebrovascular accidents (0.5%), myocardial infarctions (0.4%), and iliac artery aneurysms (0.17%). Hence, patients with recent history of cardiovascular accidents or significant cardiovascular comorbidities and patients who could not tolerate intravitreal injections might also find laser therapy a better option in treating DME.
Therefore, it is still useful to compare the effectiveness of conventional focal/grid laser versus subthreshold micropulse in treating DME in our clinical context. Previous studies [12], [13], [14] had mainly demonstrated non-inferiority of subthreshold micropulse laser in terms of best-corrected visual acuity (BCVA), contrast sensitivity and central retinal thickness. Nonetheless, majority of the studies demonstrated that laser scars were much more frequently identified in conventional laser than micropulse laser-treated eyes.
Optical coherence tomography angiography (OCT-A) is a new, non-invasive imaging technique to visualize the retinal vasculature and choroidal vascular layers in the macular area. It employs motion contrast imaging to high-resolution volumetric blood flow information, generating angiographic images in seconds. The principle of OCT-A involves the comparison of decorrelation signal between sequential Optical Coherence Tomography (OCT) B-scans taken at precisely the same cross-section, therefore constructing a map of blood flow. Given that only erythrocyte movements in the blood vessels are represented and axial bulk motions are eliminated, determining a vascular decorrelation signal enables visualization of 3-dimensional retinal and choroidal vascular network without the administration of intravenous dye and thus reducing the risk of potential adverse events [17], [22].
The authors believe that OCT-A can be used as a new assessment tool in comparing the efficacy of conventional focal laser versus subthreshold micropulse laser in the treatment of DME. We hypothesize that subthreshold micropulse laser is superior to focal laser in treating patients with DME in terms of OCT-A parameters. We expect the reduction in the studied OCT-A parameters (i.e. FAZ area, area of cysts, number of microaneurysms, etc.) in patients receiving subthreshold micropulse laser will be greater than focal laser by 30%.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grid laser | – | Procedure: lasergrid laser is one of the more conventional treatments for diabetic macular edema |
| micropulse laser | – | Procedure: lasermicropulse laser is one of the more recent treatments for diabetic macular edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic macular edema and central retinal thickness >400micrometers who have not received any treatments within 6 months
Key inclusion criteria (4 listed)
- Patients with best-corrected visual acuity better than 20/200 (checked with refraction test)
- Patients with clinically significant diabetic macular edema (DME) who have not received any treatment within 6 months
- Patients with central retinal thickness equal / above to around 400 um
- Patients who are able to have regular visits after laser treatment for at least 6 months
Key exclusion criteria (9 listed)
- Children under the age of 18
- Patients with proliferative diabetic retinopathy
- Patients with co-existing retinal or macular disease, including epiretinal membrane and vitreomacular traction
- Patients with previous history of laser photocoagulation, anti-VEGF injection, intravitreal steroid injection, vitreoretinal or cataract surgery within a period of 6 months
- Patients with history of uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lasergrid vs micropulse laser | Procedure or surgery | Grid laser, micropulse laser |
Primary outcome
Change in Best Corrected Visual Acuity
Time frame: 1 month, 3 month and 6 months
1 secondary outcome
Change in OCTA parameters
Time frame: 1 month, 3 month and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 27859570Quan J, Li TK, Pang H, Choi CH, Siu SC, Tang SY, Wat NMS, Woo J, Johnston JM, Leung GM. Diabetes incidence and prevalence in Hong Kong, China during 2006-2014. Diabet Med. 2017 Jul;34(7):902-908. doi: 10.1111/dme.13284. Epub 2016 Nov 29.
- Background: PubMed 2866759Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
- Background: PubMed 28351052Bandello F, Battaglia Parodi M, Lanzetta P, Loewenstein A, Massin P, Menchini F, Veritti D. Diabetic Macular Edema. Dev Ophthalmol. 2017;58:102-138. doi: 10.1159/000455277. Epub 2017 Mar 28.
- Background: PubMed 26107035Wan KH, Chen LJ, Young AL. Screening and Referral of Diabetic Retinopathy: A Comparative Review of the Practice Guidelines. Asia Pac J Ophthalmol (Phila). 2013 Sep-Oct;2(5):310-6. doi: 10.1097/APO.0b013e31829df4a3.
- Background: PubMed 11527957Qaum T, Xu Q, Joussen AM, Clemens MW, Qin W, Miyamoto K, Hassessian H, Wiegand SJ, Rudge J, Yancopoulos GD, Adamis AP. VEGF-initiated blood-retinal barrier breakdown in early diabetes. Invest Ophthalmol Vis Sci. 2001 Sep;42(10):2408-13.
- Background: PubMed 11755841Funatsu H, Yamashita H, Noma H, Mimura T, Yamashita T, Hori S. Increased levels of vascular endothelial growth factor and interleukin-6 in the aqueous humor of diabetics with macular edema. Am J Ophthalmol. 2002 Jan;133(1):70-7. doi: 10.1016/s0002-9394(01)01269-7.
- Background: PubMed 19700194Nguyen QD, Shah SM, Heier JS, Do DV, Lim J, Boyer D, Abraham P, Campochiaro PA; READ-2 Study Group. Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in diabetes (READ-2) study. Ophthalmology. 2009 Nov;116(11):2175-81.e1. doi: 10.1016/j.ophtha.2009.04.023. Epub 2009 Aug 22.
- Background: PubMed 21459215Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):615-25. doi: 10.1016/j.ophtha.2011.01.031.
- Background: PubMed 25983216Ishibashi T, Li X, Koh A, Lai TY, Lee FL, Lee WK, Ma Z, Ohji M, Tan N, Cha SB, Shamsazar J, Yau CL; REVEAL Study Group. The REVEAL Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy in Asian Patients with Diabetic Macular Edema. Ophthalmology. 2015 Jul;122(7):1402-15. doi: 10.1016/j.ophtha.2015.02.006. Epub 2015 May 14.
- Background: PubMed 25012934Korobelnik 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.
- Background: PubMed 17674014Wu L, Martinez-Castellanos MA, Quiroz-Mercado H, Arevalo JF, Berrocal MH, Farah ME, Maia M, Roca JA, Rodriguez FJ; Pan American Collaborative Retina Group (PACORES). Twelve-month safety of intravitreal injections of bevacizumab (Avastin): results of the Pan-American Collaborative Retina Study Group (PACORES). Graefes Arch Clin Exp Ophthalmol. 2008 Jan;246(1):81-7. doi: 10.1007/s00417-007-0660-z. Epub 2007 Aug 3.
- Background: PubMed 19054831Figueira J, Khan J, Nunes S, Sivaprasad S, Rosa A, de Abreu JF, Cunha-Vaz JG, Chong NV. Prospective randomised controlled trial comparing sub-threshold micropulse diode laser photocoagulation and conventional green laser for clinically significant diabetic macular oedema. Br J Ophthalmol. 2009 Oct;93(10):1341-4. doi: 10.1136/bjo.2008.146712. Epub 2008 Dec 3.
- Individual participant dataSharing planned: Undecided
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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.
Gabriel HK Li, M.B. Ch.B principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Chinese University of Hong Kong at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel KH Li, M.B. Ch.B (35052878, gabriellikh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best Corrected Visual Acuity (time frame: 1 month, 3 month and 6 months). 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 NCT05416099, which also lists 21 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 13 Jun 2022.