Not recruiting

Study of BP05 and Ranibizumab Efficacy and Safety in Patients with Wet Age-Related Macular Degeneration

Registered 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 study focuses on investigating treatments for wet age-related macular degeneration (wAMD), a condition where abnormal blood vessels form under the retina, leading to vision loss. The study evaluates two treatments: a medication called BP05 and another known as Lucentis, with both containing an active ingredient named ranibizumab. Both are administered as an injection directly into the eye. The purpose of the study is to compare the effectiveness and safety of BP05 against Lucentis in people with wAMD.

Participants are randomly assigned to receive either BP05 or Lucentis, and both the participants and the doctors will not know which treatment is given to maintain objectivity in the results. This type of study is known as "double-blind." Some participants may also receive a placebo, a treatment with no active medication, to further assess the effectiveness of these drugs.

The study aims to assess how well these treatments can improve vision by measuring changes in visual acuity, which determines the clarity of vision, and other factors such as the size of areas affected by the disease in the eye. The study will involve several visits and tests over time to track improvements or side effects, helping to gather comprehensive data on the impacts of these treatments.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of eye examinations.
The eye examinations involve checking visual acuity using the ETDRS chart and imaging tests like FA and OCT to assess the condition of the eye.
Step 2
Randomization and baseline measurements
Participants are randomly assigned to receive either the study drug BP05 or Lucentis.
Baseline measurements of visual acuity and eye condition are recorded for future comparison.
Step 3
Treatment administration
The treatment involves an injection of the assigned medication into the eye. This is known as intravitreal use.
The medication used is either BP05 or Lucentis, both containing the active substance ranibizumab.
Step 4
Follow-up visits and assessments
Regular follow-up visits are scheduled to monitor the effects of the treatment. These occur at specific intervals, such as Week 4, Week 8, Week 16, Week 24, and Week 52.
During these visits, visual acuity is assessed, and imaging tests are repeated to evaluate changes in the eye condition.
Step 5
Final evaluation
At the end of the study period, a final evaluation is conducted to assess the overall effectiveness and safety of the treatment.
This includes a comprehensive review of all collected data, including visual acuity changes and any side effects experienced.

Who can join the trial?

8 criteria

The patient or their legally authorized representative must be able to understand and sign a written consent form, agreeing to follow the study's rules.
The patient must be willing and able to attend all scheduled visits and assessments as determined by the study doctor.
The patient must be at least 50 years old at the time of screening.
The patient must have been diagnosed with an active subfoveal CNV lesion due to AMD in the study eye. Active CNV means there is leakage and fluid in or under the retina, confirmed by special eye tests.
The area of CNV must be at least 50% of the total lesion area in the study eye, confirmed by a central reading center before the study starts.
The total lesion area must be no larger than 12 disc areas in size, including blood, scars, and new blood vessel growth, confirmed by special eye tests before the study starts.
The patient must have a best corrected visual acuity between 20/40 and 20/200 in the study eye, measured using an ETDRS chart at screening.
Female patients who cannot have children (e.g., permanently sterilized or postmenopausal) or female patients who can have children, as well as male patients with partners, must agree to use at least two forms of effective birth control from screening until three months after the last injection of the study drug.

Who cannot join the trial?

8 criteria

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery in the last three months.
Patients who are currently using other treatments for wet macula degeneration, which is a condition affecting the central part of the retina in the eye.
Patients with uncontrolled high blood pressure.
Patients with a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients with any serious health conditions that could interfere with the study.

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Investigated drugs

BP05
is a biosimilar candidate being tested for its effectiveness in treating wet age-related macular degeneration (wAMD). It is designed to work similarly to an existing medication, aiming to help reduce the abnormal growth of blood vessels in the eye, which can lead to vision loss.
Lucentis
is a medication already approved in the European Union for the treatment of wet age-related macular degeneration. It helps to slow down the progression of the disease by inhibiting the growth of abnormal blood vessels in the eye, thereby helping to preserve vision.

Ranibizumab

What is already known about the treatment

Lucentis – This medication is administered through an injection directly into the eye and is primarily used to treat wet age-related macular degeneration, a condition that affects vision. Lucentis is well-established in medical literature and is widely used in clinical practice. It works by inhibiting a protein called vascular endothelial growth factor (VEGF), which is responsible for the growth of abnormal blood vessels in the eye. Lucentis belongs to the pharmacological class of anti-VEGF agents, which help reduce vision loss by preventing these abnormal blood vessels from leaking and causing damage to the retina.

Investigated diseases

Wet Macular Degeneration – This is a chronic eye disorder that causes blurred vision or a blind spot in your visual field. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause damage to the macula, the part of the retina responsible for central vision. Over time, the damage can lead to rapid and severe vision loss. The progression of the disease can vary, with some individuals experiencing a gradual worsening of symptoms, while others may notice a sudden change in vision. Regular monitoring and eye examinations are crucial to track the progression of this condition.