Retinal DiseaseNCT03712670
Nutraceutical Support With Omega-3
A study testing Aflibercept, Pranoprofen and Carotenoids in people with Retinal Disease, run by Università degli Studi di Brescia.
Trial summary
Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Aflibercept, Pranoprofen and Carotenoids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 15 Mar 2017
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provision of written informed consent and compliance with study assessments for the full duration of the study
- age > 40 years
- presence of treatment-naïve neovascular AMD
Who cannot join
- any previous intravitreal treatment
- previous laser treatment in the study eye
- myopia > 7 diopters in the study eye
- concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
- concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
- known sensitivity to any component of the formulations being investigated.
About this study
Official title: Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial
Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver.
Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.
- Conditions
- Retinal Disease
- Being tested
- Aflibercept, Pranoprofen, Carotenoids
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
monthly intravitreal injections
PranoprofenDrug
0.1% pranoprofen 3 times a day topical eye drops administration
CarotenoidsDietary supplement
daily supplementation of nutraceutical tablets containing the AREDS2 formulation
| Study group | Role | What they receive |
|---|---|---|
| AM group | Active comparator | Intravitreal aflibercept monotherapy Receives: Drug: Aflibercept |
| AP group | Experimental | Intravitreal aflibercept along with 0.1% pranoprofen Receives: Drug: Aflibercept; Drug: Pranoprofen |
| AN group | Experimental | Intravitreal aflibercept plus daily supplementation of nutraceutical tablets Receives: Drug: Aflibercept; Dietary Supplement: Carotenoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Retinal Thickness (microns)
Optical Coherence Tomography will be used to assess central retinal thickness.
Measured: 12-month
Visual Acuity (LogMAR)
ETDRS charts will be used to assess best corrected visual acuity
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Semeraro, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712670
- Sponsor's protocol ID
- Oral001
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
PubMed 22840421Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
PubMed 24310343
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03712670
- Acronym / sponsor ID
- Oral001
- Conditions
- Retinal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 19 Oct 2018 (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.
Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver.
Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AM group | Active comparator | Drug: AfliberceptIntravitreal aflibercept monotherapy |
| AP group | Experimental | Drug: Aflibercept, Drug: PranoprofenIntravitreal aflibercept along with 0.1% pranoprofen |
| AN group | Experimental | Drug: Aflibercept, Dietary Supplement: CarotenoidsIntravitreal aflibercept plus daily supplementation of nutraceutical tablets |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provision of written informed consent and compliance with study assessments for the full duration of the study
- age > 40 years
- presence of treatment-naïve neovascular AMD
Key exclusion criteria (6 listed)
- any previous intravitreal treatment
- previous laser treatment in the study eye
- myopia > 7 diopters in the study eye
- concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
- concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
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 |
|---|---|---|
| Afliberceptmonthly intravitreal injections | Drug | AM group, AN group, AP group |
| Pranoprofen0.1% pranoprofen 3 times a day topical eye drops administration | Drug | AP group |
| Carotenoidsdaily supplementation of nutraceutical tablets containing the AREDS2 formulation | Dietary supplement | AN group |
Primary outcome
Central Retinal Thickness (microns)
Time frame: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness.
Visual Acuity (LogMAR)
Time frame: 12-month
ETDRS charts will be used to assess best corrected visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Background: PubMed 22840421AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
- Background: PubMed 24310343Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept, Pranoprofen and Carotenoids in people with Retinal Disease, run by Università degli Studi di Brescia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Central Retinal Thickness (microns) (time frame: 12-month). 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?
On the ClinicalTrials.gov record for NCT03712670, which also lists 2 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 19 Oct 2018.