Retinopathy, DiabeticPhase 4NCT04362241
DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery
A Phase 4 study testing Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] in people with Retinopathy, Diabetic, run by Ophthalmic Consultants of the Capital Region at 1 site in United States.
Trial summary
The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinopathy, Diabetic
- What is being tested?
- Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to Mar 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Binocular
- >18 years old
- Any level of Background Diabetic Retinopathy
- Cataract surgery candidate in each eye
- Pre-operative OCT and Fluorescein Angiography showing no Macular edema
Who cannot join
- Participant cannot complete second eye operation within 60 days of the first cataract surgery
- Maintains regular use of systemic or ocular steroids at time of enrollment
- Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
- Anterior chamber cells present at time of enrollment
- Recent febrile illness that precludes or delays participation for 90 days
- Pregnancy or lactation
Show all 17Show fewer
- Known allergy to dexamethasone
- Known allergy to prednisolone
- Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.
- Posterior capsule rupture or other intraoperative complication in first eye operated on
- Amblyopia
- Anti-VEGF injections within 6 months prior to surgery day.
- Intraocular steroid injection within 6 months prior to surgery day.
- Intraocular surgeries within 6 months prior to surgery day.
- Laser photocoagulation within 30 days prior to surgery day.
- Any type of eye inflammation
- Any punctum inflammation or dacryocystitis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ophthalmic Consultants of the Capital Region
Troy, New York, 12180
Suzanne Alterman, RN, BSN, 518-274-3123, salterman@ophthalmicconsultants.com
About this study
Official title: DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery
The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.
Read the detailed description
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the incidence of PME in diabetic patients with any level of background diabetic retinopathy undergoing cataract surgery treated with a 0.4mg dexamethasone intracanalicular insert when compared to standard of care prednisolone acetate 1% QID/1 week, TID/ 1 week, BID/ 1 week, QD/1 week. Topical NSAIDs will not be used in this study and all patients will receive an intracameral injection of moxifloxacin at the end of the surgical procedure. After screening a patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo cataract surgery on separate days. The second eye will be operated on within 60 days of the first eye's surgery. One eye will be randomized to receive the dexamethasone insert using a coin flip. The other eye will be prescribed a prednisolone acetate 0.1% eye drop QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen. The dexamethasone insert will be placed 2-4 days before surgery (Day -4 to Day-2) and those randomized to receive prednisolone acetate will start 2-4 days before surgery. After surgery, each eye will be followed for a period of approximately 60 days, consisting of four post-op follow-up visits (eight total post-op visits per patient). Primary and secondary endpoints will be assessed alongside standard-of-care procedures at all study visits . Adjusting for the enrollment period, the study will last a total of approximately 12 months.
- Conditions
- Retinopathy, Diabetic
- Being tested
- Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]Drug
Also called Prednisolone Acetate 1%
Prednisolone Acetate 1% ophthalmic drops
| Study group | Role | What they receive |
|---|---|---|
| Dextenza | Experimental | Sustained release Dexamethasone 0.4mg Receives: Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] |
| Prednisolone Acetate 1% | Active comparator | Prednisolone Acetate Ophthalmic drops Receives: Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 7 on Optical Coherence Tomography at Day 7 by a masked grader.
Measured: 7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on optical coherence tomography at Day 30 by a masked grader.
Measured: 30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 60 and on optical coherence tomography at Day 60 by a masked grader.
Measured: 60 days
Secondary outcomes (14)
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Mean central subfield thickness (CST) at Day 7 post op in each group and comparison between groups.
Measured: 7days
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Mean central subfield thickness (CST) at Day 30 post op in each group and comparison between groups.
Measured: 30 days
Incidence of central subfield thickness (CST) at Day 60 post op as seen on optical coherence tomography (OCT)
Mean central subfield thickness (CST) at Day 60 post op in each group and comparison between groups.
Measured: 60 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.
Measured: 7 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.
Measured: 30 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.
Measured: 60 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 7 post op
Measured: 7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 30 post op
Measured: 30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 60 post op
Measured: 60 days
Difference patients with absence of anterior chamber (AC) cells at Day 7 post op
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 7
Measured: 7 days
Difference patients with absence of anterior chamber (AC) cells at Day 30 post op
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 30
Measured: 30 days
Difference patients with absence of anterior chamber (AC) cells at Day 60 post op
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 60
Measured: 30 days
Self reported patient experience of comfort
Self-reported patient experience of comfort (right eye vs. left eye) at Day 60.
Measured: 60 days
Rescue Therapy
Percentage of eyes rescued in each group.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start7 Aug 2020
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy, DiabeticStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective study will use a fellow-eye design for 30 participants, summing to 60 eyes total. All eyes will receive cataract surgery. Per participant, one eye will be randomized to receive DEXTENZA® insertion at the end of the surgery, while the other eye will be assigned to a standard of care prednisolone acetate 1% eye drop regimen.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of the Capital Region
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Feldman, MD, Principal investigator, Ophthalmic Consultants of the Capital Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362241
- Sponsor's protocol ID
- OphthalmicConsultantsOC
- Status last verified
- Aug 2020
- First submitted
- 10 Apr 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT04362241
- Acronym / sponsor ID
- OphthalmicConsultantsOC
- Conditions
- Retinopathy, Diabetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ophthalmic Consultants of the Capital RegionUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 24 Apr 2020 (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 complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.
Detailed description
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the incidence of PME in diabetic patients with any level of background diabetic retinopathy undergoing cataract surgery treated with a 0.4mg dexamethasone intracanalicular insert when compared to standard of care prednisolone acetate 1% QID/1 week, TID/ 1 week, BID/ 1 week, QD/1 week. Topical NSAIDs will not be used in this study and all patients will receive an intracameral injection of moxifloxacin at the end of the surgical procedure. After screening a patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo cataract surgery on separate days. The second eye will be operated on within 60 days of the first eye's surgery. One eye will be randomized to receive the dexamethasone insert using a coin flip. The other eye will be prescribed a prednisolone acetate 0.1% eye drop QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen. The dexamethasone insert will be placed 2-4 days before surgery (Day -4 to Day-2) and those randomized to receive prednisolone acetate will start 2-4 days before surgery. After surgery, each eye will be followed for a period of approximately 60 days, consisting of four post-op follow-up visits (eight total post-op visits per patient). Primary and secondary endpoints will be assessed alongside standard-of-care procedures at all study visits . Adjusting for the enrollment period, the study will last a total of approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective study will use a fellow-eye design for 30 participants, summing to 60 eyes total. All eyes will receive cataract surgery. Per participant, one eye will be randomized to receive DEXTENZA® insertion at the end of the surgery, while the other eye will be assigned to a standard of care prednisolone acetate 1% eye drop regimen.
| Arm | Type | Receives |
|---|---|---|
| Dextenza | Experimental | Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]Sustained release Dexamethasone 0.4mg |
| Prednisolone Acetate 1% | Active comparator | Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]Prednisolone Acetate Ophthalmic drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Binocular
- >18 years old
- Any level of Background Diabetic Retinopathy
- Cataract surgery candidate in each eye
- Pre-operative OCT and Fluorescein Angiography showing no Macular edema
Key exclusion criteria (17 listed)
- Participant cannot complete second eye operation within 60 days of the first cataract surgery
- Maintains regular use of systemic or ocular steroids at time of enrollment
- Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
- Anterior chamber cells present at time of enrollment
- Recent febrile illness that precludes or delays participation for 90 days
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 |
|---|---|---|
| Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]Also: Prednisolone Acetate 1%Prednisolone Acetate 1% ophthalmic drops | Drug | Dextenza, Prednisolone Acetate 1% |
Primary outcome
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Time frame: 7 days
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 7 on Optical Coherence Tomography at Day 7 by a masked grader.
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Time frame: 30 days
Percentage of eyes that developed post-surgical PME in each group measured on optical coherence tomography at Day 30 by a masked grader.
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.
Time frame: 60 days
Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 60 and on optical coherence tomography at Day 60 by a masked grader.
14 secondary outcomes
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Time frame: 7days
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Time frame: 30 days
Incidence of central subfield thickness (CST) at Day 60 post op as seen on optical coherence tomography (OCT)
Time frame: 60 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Time frame: 7 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Time frame: 30 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.
Time frame: 60 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Time frame: 7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Time frame: 30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.
Time frame: 60 days
Difference patients with absence of anterior chamber (AC) cells at Day 7 post op
Time frame: 7 days
Difference patients with absence of anterior chamber (AC) cells at Day 30 post op
Time frame: 30 days
Difference patients with absence of anterior chamber (AC) cells at Day 60 post op
Time frame: 30 days
Self reported patient experience of comfort
Time frame: 60 days
Rescue Therapy
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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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.
Robert Feldman, MD principal investigator
Ophthalmic Consultants of the Capital Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE] in people with Retinopathy, Diabetic, run by Ophthalmic Consultants of the Capital Region at 1 site 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 5 inclusion and 17 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 11 Aug 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Suzanne Alterman, RN, BSN (518-274-3123, salterman@ophthalmicconsultants.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure. (time frame: 7 days). The study lists 3 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 11 Aug 2020.