NCT03712670

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 17, 2018

Last Update Submit

October 17, 2018

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (2)

  • Central Retinal Thickness (microns)

    Optical Coherence Tomography will be used to assess central retinal thickness.

    12-month

  • Visual Acuity (LogMAR)

    ETDRS charts will be used to assess best corrected visual acuity

    12-month

Study Arms (3)

AM group

ACTIVE COMPARATOR

Intravitreal aflibercept monotherapy

Drug: Aflibercept

AP group

EXPERIMENTAL

Intravitreal aflibercept along with 0.1% pranoprofen

Drug: AfliberceptDrug: Pranoprofen

AN group

EXPERIMENTAL

Intravitreal aflibercept plus daily supplementation of nutraceutical tablets

Drug: AfliberceptDietary Supplement: Carotenoids

Interventions

AfliberceptDRUG

monthly intravitreal injections

AM groupAN groupAP group
PranoprofenDRUG

0.1% pranoprofen 3 times a day topical eye drops administration

AP group
CarotenoidsDIETARY_SUPPLEMENT

daily supplementation of nutraceutical tablets containing the AREDS2 formulation

AN group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22840421BACKGROUND

  • Age-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.

    PMID: 24310343BACKGROUND

MeSH Terms

Conditions

Retinal Diseases

Interventions

afliberceptpyranoprofenCarotenoids

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Francesco Semeraro

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

March 15, 2017

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share