Diabetic Macular EdemaPhase 3Anti-VEGFNCT04063358
Anti-VEGF Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
A Phase 3 study testing Lucentis in people with Diabetic Macular Edema and Cataract, run by Second Military Medical University at 1 site in China.
Trial summary
The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Cataract
- What is being tested?
- Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2019to 31 Aug 2021
- Phase
- Phase 3
- 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
Who may be able to join
- Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery
Who cannot join
- Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
- Patients with history of vitrectomy. Patients with neovascular glaucoma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 86-21
dongyan pan, 86-21-31161995, campus@126.com
About this study
Official title: Timing of Anti-vascular Endothelial Growth Factor（Anti-VEGF） Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery
The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Read the detailed description
Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
- Conditions
- Diabetic Macular Edema, Cataract
- Being tested
- Lucentis
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucentisDrug
Lucentis 0.5 MG Per 0.05 ML Injection
| Study group | Role | What they receive |
|---|---|---|
| Lucentis injected Pre-operatively | Experimental | Lucentis injected 2 weeks before cataract surgery Receives: Drug: Lucentis |
| Lucentis injected intra-operatively | Active comparator | Lucentis injected during the course of the surgery by cataract surgeon. Receives: Drug: Lucentis |
| Lucentis injected post-operatively | Experimental | Lucentis injected 2 weeks after cataract surgery Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity (BCVA)
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Measured: 1 month, 3 months , 6 months and 12 months after cataract surgery
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.
Measured: 24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery
Secondary outcomes (2)
Total number of postoperative injections
Total number of postoperative injections will be calculated
Measured: 12 months after cataract surgery
percentage of patients with diabetic retinopathy progression
patients with diabetic retinopathy progression will be calculated
Measured: 12 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start22 Aug 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pandongyan, Second Military Medical University
- Investigators
- wei shen, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063358
- Sponsor's protocol ID
- SecondMMU2019
- Acronym
- Anti-VEGF
- Status last verified
- Mar 2020
- First submitted
- 19 Aug 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Anti-vascular Endothelial Growth Factor（Anti-VEGF） Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT04063358
- Acronym / sponsor ID
- Anti-VEGF / SecondMMU2019
- Conditions
- Diabetic Macular Edema, Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 21 Aug 2019 (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 investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Detailed description
Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lucentis injected Pre-operatively | Experimental | Drug: LucentisLucentis injected 2 weeks before cataract surgery |
| Lucentis injected intra-operatively | Active comparator | Drug: LucentisLucentis injected during the course of the surgery by cataract surgeon. |
| Lucentis injected post-operatively | Experimental | Drug: LucentisLucentis injected 2 weeks after cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery
Key exclusion criteria (2 listed)
- Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
- Patients with history of vitrectomy. Patients with neovascular glaucoma
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 |
|---|---|---|
| LucentisLucentis 0.5 MG Per 0.05 ML Injection | Drug | Lucentis injected Pre-operatively, Lucentis injected intra-operatively, Lucentis injected post-operatively |
Primary outcome
Change in best-corrected visual acuity (BCVA)
Time frame: 1 month, 3 months , 6 months and 12 months after cataract surgery
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Time frame: 24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.
2 secondary outcomes
Total number of postoperative injections
Time frame: 12 months after cataract surgery
percentage of patients with diabetic retinopathy progression
Time frame: 12 months after cataract surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- 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.
wei shen principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lucentis in people with Diabetic Macular Edema and Cataract, run by Second Military Medical University 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 1 inclusion and 2 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 26 Mar 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 dongyan pan (86-21-31161995, campus@126.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 (BCVA) (time frame: 1 month, 3 months , 6 months and 12 months after cataract surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2020.