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Retinopathy of PrematurityPhase 2NCT02504944

Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)

A Phase 2 study testing Propranolol 0.2% eye drops in people with Retinopathy of Prematurity, run by Meyer Children's Hospital IRCCS at 7 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Read more about this study

Who is it for?
Any age
Conditions the study is for
Retinopathy of Prematurity
What is being tested?
Propranolol 0.2% eye drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
7 sitesItaly
Study dates
Jul 2015to Aug 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Preterm newborns (gestational age 23-32 weeks) with stage 1 ROP
  • A signed parental informed consent

Who cannot join

  • Newborns with heart failure
  • Newborns with recurrent bradycardia (heart rate < 90 beat per minute)
  • Newborns with second or third degree atrioventricular block
  • Newborns with congenital cardiovascular anomalies, except for persistent ductus arteriosus, patent foramen ovale and small ventricular septal defects
  • Newborns with hypotension
  • Newborns with renal failure
Show all 9Show fewer
  • Newborns with actual cerebral haemorrhage
  • Newborns with other diseases which contraindicate the use of beta-adrenoreceptor blockers.
  • Newborns with a more severe stage of ROP than stage 1

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Italy7 sites

  • Neonatal Intensive Care Unit, Azienda Ospedaliera Spedali Civili di Brescia

    Brescia

  • Neonatal Intensive Care Unit, A. Meyer University Childrens' Hospital

    Florence, 50139

  • Institute of Pediatrics and Neonatology, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, University of Milan

    Milan, 20122

  • Neonatal Intensive Care Unit, Azienda Ospedaliera San Gerardo

    Monza

  • Piermarocchi Stefano

    Padova, 35100

  • Neonatal Intensive Care Unit, Azienda Ospedaliera Universitaria Senese

    Siena

  • Neonatal Intensive Care Unit, Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

    Varese

Other trials in Italy

About this study

Official title: Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Newborn With Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)

The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP). Preterm newborns (gestational age 23-32 weeks) with a stage 1 ROP will receive propranolol 0.2% eye drops treatment until retinal vascularization will be completed, but no more than 90 days.

Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.

Being tested
Propranolol 0.2% eye drops
Keywords
Retinopathy of prematurity, Propranolol, Newborn, Eye Drops, Retinal angiogenesis, Retinal neovascularization
Medical subject headings
Retinopathy of Prematurity, Retinal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propranolol 0.2% eye dropsDrug

    Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, four times daily (every 6 hours). Propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP) Cooperative Group.

Study groups in NCT02504944
Study groupRoleWhat they receive
Propranolol 0.2% eye dropsExperimentalEnrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%). The treatment will be started as soon as the diagnosis of stage 1 ROP is made and will be continue until the development of retinal vascularization is completed, but no more than 90 days. Cardiovascular and respiratory parameters will be continuously monitored. Blood samplings checking metabolic, renal and liver functions will be performed periodically, as well as cardiac function, in order to verify the treatment safety. Propranolol concentrations will be measured on dried blood spots at the steady state (10th day). Serial ophthalmological evaluations will be planned to monitor the efficacy of the treatment, the ROP progression and the possible complications.
Receives: Drug: Propranolol 0.2% eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  2. Incidence rate of progression from stage 1 ROP to zone II stage 3 ROP with plus

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  3. Plasma concentrations of propranolol at the steady state measured by dried blood spots

    Measured: 10th day of treatment

Secondary outcomes (6)

  1. Number of newborns who progress to Stage 2 without plus ROP

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  2. Number of newborns who progress to Stage 3 without plus ROP

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  3. Number of newborns who progress to Stage 4 with total or partial retinal detachment

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  4. Number of newborns who progress to Stage 5 ROP with total or partial retinal detachment

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  5. Number of newborns who need vitrectomy

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

  6. Collection of adverse events due to eye drop propranolol treatment

    Measured: participants will be followed for the duration of hospital stay, an expected average of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02504944
Sponsor's protocol ID
DROP-ROP-0.2%
Status last verified
Aug 2018
First submitted
19 Jul 2015
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • Padrini L, Isacchi B, Bilia AR, Pini A, Lanzi C, Masini E, Della Bona ML, Calvani AM, Ceccantini R, la Marca G, Filippi L. Pharmacokinetics and local safety profile of propranolol eye drops in rabbits. Pediatr Res. 2014 Oct;76(4):378-85. doi: 10.1038/pr.2014.108. Epub 2014 Jul 16.

    PubMed 25029260

  • Filippi L, Cavallaro G, Bagnoli P, Dal Monte M, Fiorini P, Donzelli G, Tinelli F, Araimo G, Cristofori G, la Marca G, Della Bona ML, La Torre A, Fortunato P, Furlanetto S, Osnaghi S, Mosca F. Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives. J Pediatr. 2013 Dec;163(6):1570-1577.e6. doi: 10.1016/j.jpeds.2013.07.049. Epub 2013 Sep 18.

    PubMed 24054431

  • Dal Monte M, Casini G, la Marca G, Isacchi B, Filippi L, Bagnoli P. Eye drop propranolol administration promotes the recovery of oxygen-induced retinopathy in mice. Exp Eye Res. 2013 Jun;111:27-35. doi: 10.1016/j.exer.2013.03.013. Epub 2013 Mar 23.

    PubMed 23528535

  • Filippi L, Cavallaro G, Fiorini P, Malvagia S, Della Bona ML, Giocaliere E, Bagnoli P, Dal Monte M, Mosca F, Donzelli G, la Marca G. Propranolol concentrations after oral administration in term and preterm neonates. J Matern Fetal Neonatal Med. 2013 May;26(8):833-40. doi: 10.3109/14767058.2012.755169. Epub 2013 Jan 31.

    PubMed 23205867

  • Della Bona ML, Malvagia S, Villanelli F, Giocaliere E, Ombrone D, Funghini S, Filippi L, Cavallaro G, Bagnoli P, Guerrini R, la Marca G. A rapid liquid chromatography tandem mass spectrometry-based method for measuring propranolol on dried blood spots. J Pharm Biomed Anal. 2013 May 5;78-79:34-8. doi: 10.1016/j.jpba.2013.01.034. Epub 2013 Feb 4.

    PubMed 23434527

  • Filippi L, Cavallaro G, Berti E, Padrini L, Araimo G, Regiroli G, Raffaeli G, Bozzetti V, Tagliabue P, Tomasini B, Mori A, Buonocore G, Agosti M, Bossi A, Chirico G, Aversa S, Fortunato P, Osnaghi S, Cavallotti B, Suzani M, Vanni M, Borsari G, Donati S, Nascimbeni G, Nardo D, Piermarocchi S, la Marca G, Forni G, Milani S, Cortinovis I, Calvani M, Bagnoli P, Dal Monte M, Calvani AM, Pugi A, Villamor E, Donzelli G, Mosca F. Propranolol 0.2% Eye Micro-Drops for Retinopathy of Prematurity: A Prospective Phase IIB Study. Front Pediatr. 2019 May 7;7:180. doi: 10.3389/fped.2019.00180. eCollection 2019.

    PubMed 31134171

  • Filippi L, Cavallaro G, Berti E, Padrini L, Araimo G, Regiroli G, Bozzetti V, De Angelis C, Tagliabue P, Tomasini B, Buonocore G, Agosti M, Bossi A, Chirico G, Aversa S, Pasqualetti R, Fortunato P, Osnaghi S, Cavallotti B, Vanni M, Borsari G, Donati S, Nascimbeni G, la Marca G, Forni G, Milani S, Cortinovis I, Bagnoli P, Dal Monte M, Calvani AM, Pugi A, Villamor E, Donzelli G, Mosca F. Study protocol: safety and efficacy of propranolol 0.2% eye drops in newborns with a precocious stage of retinopathy of prematurity (DROP-ROP-0.2%): a multicenter, open-label, single arm, phase II trial. BMC Pediatr. 2017 Jul 14;17(1):165. doi: 10.1186/s12887-017-0923-8.

    PubMed 28709412

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol 0.2% eye drops in people with Retinopathy of Prematurity, run by Meyer Children's Hospital IRCCS at 7 sites in Italy.

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 2 inclusion and 9 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. 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 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?

Incidence rate of progression from stage 1 ROP to zone II stage 2 ROP with plus (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 months). 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?

On the ClinicalTrials.gov record for NCT02504944, which also lists 7 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 31 Aug 2018.

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