Not recruitingRare disease

Study on Dexamethasone Eye Drops for Infants with Retinopathy of Prematurity

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Retinopathy of Prematurity (ROP), which affects the eyes of premature infants. The study is investigating the use of Dexamethasone eye drops as a treatment. Dexamethasone is a type of medication known as a steroid, which can help reduce inflammation. The trial will compare the effects of Dexamethasone eye drops to a placebo to see if it can prevent the need for conventional ROP treatments in infants.

The purpose of the study is to determine if using Dexamethasone eye drops can reduce the number of infants who require standard treatments for ROP. Participants in the study will receive either the Dexamethasone eye drops or a placebo. The study will monitor the infants over a period to see if the eye drops help in preventing the progression of ROP. The study will also look at other factors such as the time it takes for ROP to progress, any recurrences after treatments like laser therapy, and the overall eye health of the infants at different ages.

Throughout the study, various assessments will be conducted, including checking the pressure inside the eyes and examining the structure of the retina using a method called optical coherence tomography (OCT). The study will also evaluate the visual outcomes and any vision-related issues as the children grow older. Additionally, leftover blood samples from routine clinical tests will be analyzed to explore any biological markers related to ROP development and treatment effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the infant's eligibility is confirmed based on specific criteria. These include a gestational age of less than 30 weeks and a diagnosis of retinopathy of prematurity (ROP) in certain stages, as confirmed by specialized eye photography and two ophthalmologists.
Parental consent is required, which involves receiving both oral and written information about the study.
Step 2
Treatment administration
The infant will receive dexamethasone eye drops as part of the treatment. These drops are administered to the eyes to potentially reduce the need for conventional ROP treatment.
The dosage and frequency of the eye drops will be determined by the study protocol and administered by healthcare professionals.
Step 3
Monitoring and assessments
Throughout the study, the infant's eye condition will be closely monitored. This includes regular eye examinations to track any progression of ROP.
Measurements of intraocular pressure will be taken before treatment, at 1 and 2 weeks after starting treatment, and after completing treatment.
Step 4
Follow-up evaluations
Follow-up evaluations will occur at 40 weeks postmenstrual age and at 2 and 5.5 years of age. These evaluations will include assessments of retinal health and visual outcomes.
Additional tests may include optical coherence tomography (OCT) to examine the structure of the retina and assessments of visual acuity and refractive errors.
Step 5
Completion of the study
The study is expected to conclude by the end of 2024. At this point, all data collected will be analyzed to determine the effectiveness of the dexamethasone eye drops in preventing the progression of ROP.
Parents will be informed of the study's findings and any implications for their child's health.

Who can join the trial?

6 criteria

Babies born with a gestational age of less than 30 weeks. Gestational age means how many weeks the baby was in the mother's womb before birth.
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Babies with specific types of Retinopathy of Prematurity (ROP), which is an eye condition affecting premature babies. This includes:
- Zone I ROP without plus disease with either Stage 1 or Stage 2 ROP.
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  Zone II ROP without plus disease with either:
  - Posterior ROP Stage 2
  - ROP Stage 3 with or without a notch in Zone I
  - The stage of ROP must be confirmed using RetCam photography, which is a special camera used to take pictures of the inside of the eye, and verified by two eye doctors (ophthalmologists).
  - Parents must give their informed consent, meaning they agree to the baby's participation after receiving both oral and written information about the study.

Who cannot join the trial?

5 criteria

Infants who have any other serious eye conditions apart from Retinopathy of Prematurity.
Infants who have had previous eye surgery.
Infants who are currently receiving other treatments that might interfere with the study.
Infants with known allergies to Dexamethasone or any of its components. Dexamethasone is a type of medication used to reduce inflammation.
Infants who have any other serious health conditions that the study doctors think might make it unsafe for them to participate.

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Verified sites

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Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
Responsive
Region Oestergoetland
Linkoping, Sweden
Responsive
Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Dexamethasone is an eye drop medication used in this clinical trial to help prevent a condition called proliferative retinopathy of prematurity, which can affect the eyes of premature infants. The goal of using these eye drops is to see if they can reduce the number of infants who need more traditional treatments for this eye condition. Dexamethasone works by reducing inflammation and swelling, which may help protect the eyes from damage. In this study, the medication is applied directly to the eyes in the form of drops.

Dexamethasone Phosphate

What is already known about the treatment

Dexamethasone – Dexamethasone is administered as eye drops and is currently being studied for its potential to prevent the need for conventional treatment in infants with retinopathy of prematurity, a condition affecting the eyes of premature babies. In medical literature, it is recognized for its anti-inflammatory properties and is being evaluated in clinical trials for this specific use. The main therapeutic indication in this study is to reduce the progression of proliferative retinopathy in premature infants. At the molecular level, dexamethasone works by suppressing inflammation and immune responses, which can help in reducing abnormal blood vessel growth in the eye. It is classified pharmacologically as a corticosteroid, which is a type of medication that mimics hormones produced by the adrenal glands to reduce inflammation.

Investigated diseases

Retinopathy of Prematurity – Retinopathy of Prematurity is a disease that affects the eyes of premature infants. It occurs when abnormal blood vessels grow in the retina, the layer of tissue at the back of the inner eye. This abnormal growth can cause the retina to detach from the back of the eye, potentially leading to vision problems. The disease progresses through several stages, starting with mild changes in the retina and potentially advancing to more severe forms where the retina may detach. The progression can vary, with some infants experiencing spontaneous improvement while others may progress to more severe stages. Monitoring and timely intervention are crucial to manage the condition effectively.