Research Studies

Clinical trial registration #

 

Trial short name

 

Author (year)

 

Citation

 

Country

 

Study period

 

Study design

 

Study population

Characteristics

 

Type of AMD (Dry=1; Wet AMD=2)

 

AMD stage (0=Normal; 1=Early; 2=Intermediate; 3=Late)

 

Total Sample Size of patients (eyes), n

 

Total sample age (years), mean±SD or specified

 

Experimental group

Intervention therapy

 

# of patients

 

Age (years), mean ± SD

 

Male, n (%)

 

# of patients completed the follow up

 

Control group

Control therapy

 

# of patients

 

Age (years), mean ± SD

 

Male, n (%)

 

# of patients completed the follow up

 

Follow up time

 

Primary Outcome

 

Efficacy: Vision outcomes

Best-corrected visual acuity (BCVA), (ETDRS) letters

 

Patients maintained vision (<15-letter loss on the BCVA), in visual loss with n of loss letters on BCVA, or in visual gains with n of the gain letters on the BCVA, %

 

Efficacy: Progression

Any progression results, n (%)

 

Efficacy: Anatomic outcome

 

 



Central Retinal Thickness (CRT), central macular thickness (CMT), Central subfield thickness (CS(F)T), or central foveal thickness (CFT), μm

 

Choroidal neovascularization (CNV) area or/and CNV leakage area, total lesion area, mm2

 

Drusen Volume (Mean±SD or specified), mm3

 

Presence of intraretinal fluid (IRF), subretinal fluid (SRF), retinal pigment epithelium detachments, or sub-retinal pigmented epithelium (Sub-RPE), n (%)

 

Other

 

Durability Outcome

 

 Number of Injection (Mean or specified), n

 

Patients treated frequency during the treat-and-extend period, %

 

Patients treated duration (week or specified) during the treat-and-extend period, %

 

Safety






 Adverse event (AE), n (%)

 

Ocular AE, n (%)

 

Systemic AE , n (%)

 

Serious adverse event, n (%)

 

Treatment discontinuation, n (%)

 

Death, n (%)

 

Treatment-emergent adverse events (TEAEs)

 

Serious treatment-emergent adverse events (TEAEs), n

 

QoL

 

 

Resource utility

 

 

Pharmacokinetics

 

 

Immunogenicity results

 

Conclusion

 

Risk of bias assessment for the primary outcome

Randomization process

 

Deviations from intended interventions

 

Missing outcome data

 

Measurement of the outcome

 

Selection of the reported result

 

Overall