Here is the design of a clinical trial:

Official Title: A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study

Included conditions:
- Diabetic Retinopathy

Study Armgroups:
- {'label': 'Single-rising dose part - low dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.', 'interventionNames': ['Drug: BI 764524']}
- {'label': 'Single-rising dose part - medium dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.', 'interventionNames': ['Drug: BI 764524']}
- {'label': 'Single-rising dose part - high dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.', 'interventionNames': ['Drug: BI 764524']}
- {'label': 'Multiple dosing part - Sham', 'type': 'SHAM_COMPARATOR', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.', 'interventionNames': ['Drug: Sham control of BI 764524']}
- {'label': 'Multiple dosing part - high dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.', 'interventionNames': ['Drug: BI 764524']}

Interventions:
- {'type': 'DRUG', 'name': 'BI 764524', 'description': 'BI 764524', 'armGroupLabels': ['Multiple dosing part - high dose BI 764524', 'Single-rising dose part - high dose BI 764524', 'Single-rising dose part - low dose BI 764524', 'Single-rising dose part - medium dose BI 764524']}
- {'type': 'DRUG', 'name': 'Sham control of BI 764524', 'description': 'Sham control of BI 764524', 'armGroupLabels': ['Multiple dosing part - Sham']}

Primary Outcomes:
- {'measure': 'Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8', 'description': 'Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).', 'timeFrame': 'From drug administration (day 1) till day 8, Up to 7±2 days.'}
- {'measure': 'Multiple Dosing (MD) Part - the Number of Patients With Drug-related Adverse Events (AEs) From Drug Administration Until End of Trial.', 'description': 'Multiple dosing (MD) part - the number of patients with drug-related Adverse Events (AEs) from drug administration until End of Trial.', 'timeFrame': 'From drug administration (day 1) till End of Trial, up to 23 weeks.'}

Please estimate the sample size based on the assumption: 
No formal statistical power calculations for the SRD part as it is explorative. The sample size for the MD part is based on the estimated likelihood of observing a treatment effect given the mean intraindividual variability of FAZ estimates.
Sample size {14}
        No formal statistical power calculations to determine sample size will be performed for the SRD part as it is an explorative phase. Based on the simulation study conducted to evaluate operating characteristics of the BLRM, about 15 evaluable subjects are expected to be treated in the dose-escalation part for the model to ensure reasonable operating characteristics relating to the maximum feasible dose recommendation. Sample size was calculated for the MD part based on the estimated likelihood of observing a treatment effect given the mean intraindividual variability of FAZ estimates, which have been previously derived [30]. Assuming a mean treatment difference of 10%, with 20 subjects in the BI 764524 arm and 10 subjects in the sham arm, the likelihood of observing a treatment effect larger than 6% (reduction in size of the FAZ of 0.0462 mm2) is 81.7%, and the likelihood of observing a treatment effect smaller than 4% (reduction in size of the FAZ of 0.0308 mm2) is 10.2%. With an assumed mean treatment difference of 0%, the likelihood of observing a treatment effect larger than 6% would be 12.3%, and the likelihood of observing a treatment effect smaller than 4% is 78.7%.