Diabetic Macular EdemaPhase 2NCT03920878
Cataract DME - Peri vs. Intraop
A Phase 2 study testing Aflibercept injected Pre- and Post-operatively and Aflibercept injected intraoperatively in people with Diabetic Macular Edema and Cataract, run by Emory University at 2 sites in United States.
Trial summary
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous… 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?
- Aflibercept injected Pre- and Post-operatively and Aflibercept injected intraoperatively
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2020to Jun 2020
- Phase
- Phase 2
- 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
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Grady Health System
Atlanta, Georgia, 30322
About this study
Official title: Peri- Versus Intra-operative Anti-vascular Endothelial Growth Factor Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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.
Read the detailed description
Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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
- Aflibercept injected Pre- and Post-operatively, Aflibercept injected intraoperatively
- Keywords
- anti-VEGF injections, pre-existing DME, cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept injected Pre- and Post-operativelyDrug
Also called EYELEA
Three injections of aflibercept before cataract surgery, and aflibercept injections after surgery within 14-21 days of the day of surgery (number of injections depends on clinical exam findings, visual acuity and retinal thickness).
Aflibercept injected intraoperativelyDrug
Also called EYELEA
Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept injected Pre- and Post-operatively | Experimental | Pre- and Post-operative time of Aflibercept injections Receives: Drug: Aflibercept injected Pre- and Post-operatively |
| Aflibercept injected intraoperatively | Active comparator | Intraoperative time of Aflibercept injection Receives: Drug: Aflibercept injected intraoperatively |
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 and 6 months after cataract surgery
Secondary outcomes (2)
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 and 6 months after cataract surgery
Total number of postoperative injections
Total number of postoperative injections will be calculated
Measured: 6 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 posted19 Apr 2019
- Study startMay 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: The study team was unable to secure sufficient funding and administrative support.
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.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Hendrick, Emory University
- Investigators
- Andrew Hendrick, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920878
- Sponsor's protocol ID
- IRB00106475
- Status last verified
- Dec 2020
- First submitted
- 17 Apr 2019
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri- Versus Intra-operative Anti-vascular Endothelial Growth Factor Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT03920878
- Acronym / sponsor ID
- IRB00106475
- Conditions
- Diabetic Macular Edema, Cataract
- Keywords
- anti-VEGF injections, pre-existing DME, cataract surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team was unable to secure sufficient funding and administrative support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Apr 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.
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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.
Detailed description
Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflibercept injected Pre- and Post-operatively | Experimental | Drug: Aflibercept injected Pre- and Post-operativelyPre- and Post-operative time of Aflibercept injections |
| Aflibercept injected intraoperatively | Active comparator | Drug: Aflibercept injected intraoperativelyIntraoperative time of Aflibercept injection |
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 (3 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 |
|---|---|---|
| Aflibercept injected Pre- and Post-operativelyAlso: EYELEAThree injections of aflibercept before cataract surgery, and aflibercept injections after surgery within 14-21 days of the day of surgery (number of injections depends on clinical exam findings, visual acuity and retinal thickness). | Drug | Aflibercept injected Pre- and Post-operatively |
| Aflibercept injected intraoperativelyAlso: EYELEAThree injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon. | Drug | Aflibercept injected intraoperatively |
Primary outcome
Change in best-corrected visual acuity (BCVA)
Time frame: 1 month, 3 months and 6 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.
2 secondary outcomes
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Time frame: 24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery
Total number of postoperative injections
Time frame: 6 months after cataract surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No. No individual de-identified participant data (including data dictionaries) will be shared. Only composite results with publication will be shared.
Related trials for Diabetic Macular Edema
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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
Andrew Hendrick, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept injected Pre- and Post-operatively and Aflibercept injected intraoperatively in people with Diabetic Macular Edema and Cataract, run by Emory University at 2 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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in best-corrected visual acuity (BCVA) (time frame: 1 month, 3 months and 6 months after cataract surgery). 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 24 Dec 2020.